MANAGEMENT OF LARGE FULL-THICKNESS MACULAR HOLES: Long-Term Outcomes of Internal Limiting Membrane Flaps and Internal Limiting Membrane Peels.

BACKGROUND/PURPOSE: To determine and compare the efficacy of a surgical internal limiting membrane (ILM) flap technique with the traditional ILM peel on long-term visual and anatomical outcomes for large (>400 µm) full-thickness macular holes. METHODS: From October 2016 to July 2022, patients undergoing initial full-thickness macular hole repair with the ILM flap or ILM peel technique were reviewed. Final outcomes were recorded and based on size in microns: 401 to 800, 801 to 1,200, and >1,200. RESULTS: Patients treated with ILM flap (n = 52, 94.2% closure rate) or ILM peel (n = 407, 93.6% closure rate) were followed with a mean follow-up time of 15.0 ± 10.2 and 20.0 ± 13.4 months, respectively. Success rates for ILM flaps and ILM peels were compared for full-thickness macular holes of 401 to 800 (100%, 95.8%, P = 0.39), 801 to 1,200 (95%, 93%, P = 0.74), and >1,200 (86.7%, 86.7%, P = 1.0) µm. Mean best-recorded logarithm of the minimal angle of resolution visual acuity for ILM flaps and ILM peels, respectively, was 1.02 ± 0.46 and 0.87 ± 0.47 preoperatively, with follow-up acuity of 0.48 ± 0.32 (P < 0.03) and 0.39 ± 0.42 (P < 0.01) at Year 3. CONCLUSION: Both techniques provide a similar anatomical closure rate and functional improvement in vision. Comparisons should be cautiously made based on difference in preoperative hole size.

Prostaglandin-Induced Macular Hole: A Brief Report.

This case series reports on two patients who developed macular holes while on prostaglandin analogs (PGA) therapy. The first case involves a 63-year-old woman with a history of a macular hole of the left eye that had spontaneously closed. After starting PGA therapy for elevated intraocular pressure, cystoid macular edema formed, which resulted in reopening of the macular hole. The second case involves a 64-year-old man with primary open-angle glaucoma, on PGA therapy, with a newly diagnosed small macular hole of the right eye that closed after cessation of the PGA therapy. These cases demonstrate an association between prostaglandin analogs and the formation or reopening of full-thickness macular holes. [Ophthalmic Surg Lasers Imaging Retina 2024;55:112-115.].

USE OF OPTICAL COHERENCE TOMOGRAPHY IN DETECTING RETINAL TEARS IN ACUTE, SYMPTOMATIC POSTERIOR VITREOUS DETACHMENT.

PURPOSE: To evaluate the association of posterior vitreous opacities (PVOs) on optical coherence tomography with retinal tears identified on examination in patients with acute, symptomatic posterior vitreous detachment (PVD). METHODS: Data were retrospectively collected from the medical records of 388 patients with acute, symptomatic PVD between January 1, 2021, and June 30, 2021. Included patients had received a primary diagnosis of PVD and presented with flashes and/or floaters. Optical coherence tomography scans were reviewed by two separate readers for the presence of PVOs. The primary outcome was the presence of retinal tear on fundus photograph and on examination. RESULTS: Of 388 patients who presented with acute PVD symptoms, 90 (23.2%) were found to have a retinal tear on dilated fundus examination. Among these patients, 78 (86.7%) were found to have PVOs on optical coherence tomography. Statistical analysis demonstrated a significant relationship between the presence of PVOs and retinal tear ( P < 0.01). The sensitivity and specificity of this finding was 86.7% and 72.5%, respectively. Further analysis included area under the curve from receiver operating characteristic curve which was found to be 0.80. CONCLUSION: The presence of PVOs on optical coherence tomography is suggestive of a retinal tear in patients with acute, symptomatic PVD.

Impact of Race and Ethnicity on Presentation and Surgical Outcomes of Idiopathic Macular Holes.

There is limited data on the presentation and surgical outcomes of idiopathic macular holes (IMH) for different ethnic and racial groups. Recognition of distinct, clinically-relevant patient subgroups may provide opportunities to identify specific unmet needs including possible barriers to optimal healthcare delivery. Medical records of patients who underwent surgery for IMH (between 2016 and 2022) at a large, urban retina practice were reviewed and self-reported ethnicity (Hispanic and non-Hispanic) and race (Asian, Black, White, and Other) were captured. The primary variables included (1) mean minimum linear diameter (MLD) at presentation and (2) surgical outcome (IMH closure status). Overall, mean MLD for all study eyes (515) was 366.1 µm, and surgical success was achieved in 489 (95.0%) eyes. Hispanic eyes presented with larger mean MLD (p = 0.002) compared to non-Hispanic eyes. Asian, Black, and Other eyes presented with larger mean MLD (p = 0.033, p < 0.001, p < 0.001) when compared to White eyes. The presentation of IMH varied in severity among different ethnic and racial groups. Hispanic patients were found to have worse preoperative visual acuity (VA), longer time to surgery, and larger mean MLD and BD compared to non-Hispanic participants. Black and Other patients were found to have worse VA, time to surgery, and larger mean MLD and BD when compared to White participants.

Favorable Anti-VEGF Crunch Syndrome: Nonsurgical Relief of Vitreoretinal Traction in Eyes With Proliferative Diabetic Retinopathy and Tractional Retinal Detachment.

Herein are reported four eyes among three patients with favorable anti-vascular endothelial growth factor crunch syndrome by which contraction of fibrovascular tissue led to relief of vitreoretinal traction without surgical intervention. This phenomenon led to complete or partial retinal reattachment in two patients with diabetic tractional retinal detachments. These cases represent favorable anatomic outcomes of crunch syndrome secondary to anti-vascular endothelial growth factor pharmacotherapy and are unique compared with most cases, which have been associated with negative outcomes. [Ophthalmic Surg Lasers Imaging Retina 2022;53:455-459.].

Outcomes of Eyes Undergoing Multiple Surgical Interventions after Failure of Primary Rhegmatogenous Retinal Detachment Repair.

PURPOSE: To assess outcomes among eyes undergoing surgery for recurrent rhegmatogenous retinal detachment (RRD) and investigate variables that correlate with visual and anatomic outcomes. DESIGN: Retrospective, consecutive case series. PARTICIPANTS: Eyes in which initial RRD repair failed that underwent ≥2 surgeries for RRD repair between January 1, 2016, and December 31, 2020. METHODS: A retrospective analysis of eyes that underwent ≥2 RRD repairs. Eyes with etiologies of retinal detachment other than RRD, previous vitreoretinal surgery, and proliferative diabetic retinopathy were excluded. One-way analysis of variance with Tukey honestly significant difference testing and multivariate regression analyses were used to assess statistical significance. MAIN OUTCOME MEASURES: Anatomic success rate and habitual best recorded visual acuity (VA) at postoperative time intervals and at final follow-up. RESULTS: The single-operation success rate (SOSR) among eyes that underwent primary RRD repair over a 5-year period was 92.4% (2021 of 2187 eyes). The remaining 166 eyes (164 patients) in which primary RRD repair failed were included in this study. Although the anatomic success rates after the second and third RRD repairs were lower than the SOSR (71.7% and 68.1%, respectively), the final anatomic success rates did not significantly differ between eyes that underwent ≥2 RRD repairs (range, 90.6%-100%) (P > 0.05), and final anatomic success was achieved in 95.8% of the eyes. The average VA at both postoperative time intervals and final follow-up decreased with an increased total number of RRD repairs. Eyes that received silicone oil endotamponade during the second RRD repair were 20.3% (P = 0.03) and 38.4% (P = 0.04) less likely to require a third RRD repair compared with eyes that received octafluoropropane and sulfur hexafluoride gases, respectively. Eyes that developed a third RRD due to proliferative vitreoretinopathy (PVR) (n = 43) were 110% more likely to require a fourth RRD repair than eyes that developed a third RRD due to a new tear or failure to reattach (n = 4) (P = 0.04). CONCLUSIONS: In this series, the rates of anatomic success appeared consistent after each surgery when multiple reoperations were required for RRD. The VA decreased with an increased total number of RRD repairs, and the endotamponade choice might have affected the risk of additional reoperations. Proliferative vitreoretinopathy was a significant prognostic factor for RRD recurrence.

COMPARISON OF 25- AND 27-GAUGE SUTURELESS CANNULA-BASED INTRAOCULAR LENS SCLERAL FIXATION VISUAL ACUITY OUTCOMES AND COMPLICATION RATES.

PURPOSE: To compare the visual outcomes and complication rates of sutureless cannula-based intraocular lens scleral (SCILS) fixation performed with 25-gauge (25 G) versus 27-gauge (27 G) instrumentation. METHODS: A retrospective chart review of consecutive cases of eyes without capsular support that underwent SCILS fixation of a three-piece intraocular lens. Sutureless cannula-based intraocular lens scleral fixation was performed by transconjunctival use of either 25-G or 27-G trocar cannulas. During postoperative follow-up evaluations, visual acuity and intraocular pressure were measured, and slit-lamp and indirect ophthalmoscopy examinations were performed to assess for development of known complications. RESULTS: A total of 69 eyes underwent 25 G (27 eyes) or 27 G (42 eyes) SCILS fixation. The mean preoperative logarithm of the minimum angle of resolution visual acuity trended toward improvement from 0.95 ± 0.68 (20/178 Snellen equivalent) to 0.67 ± 0.64 (20/94 Snellen equivalent) for 25 G group at 1 year. Similar trend toward visual acuity improvement was seen in 27 G group with a mean preoperative logarithm of the minimum angle of resolution visual acuity of 1.43 ± 0.94 (20/538 Snellen equivalent) improving to 0.86 ± 1.00 (20/145 Snellen equivalent) at 1 year. Statistically significant improvement was seen as early as postoperative week one for 27 G group (P < 0.01), whereas statistically significant worsening was noted at the same time in 25 G group (P = 0.01). There was a statistically significant reduction in intraocular lens displacement (P = 0.01) and need for reoperation (P = 0.01) in 27 G group. CONCLUSION: Compared with 25 G SCILS fixation, eyes managed with 27 G SCILS fixation experienced more rapid visual acuity improvement. In addition, there was a lower rate of complications including intraocular lens displacement and need for reoperation.

THE TEXAS TACO TECHNIQUE FOR INTERNAL LIMITING MEMBRANE FLAP IN LARGE FULL-THICKNESS MACULAR HOLES: A Short-Term Pilot Study.

PURPOSE: To determine the efficacy of a novel application of a surgical internal limiting membrane flap technique that requires no additional surgical adjuvants in closure of large full-thickness macular holes (FTMHs). METHODS: The electronic medical records of patients (n = 8) with large (>400 µm) FTMHs repaired with the "Texas Taco" technique were retrospectively reviewed. RESULTS: Operated patients had a mean age of 63.8 ± 19.2 (range, 19-80) years. There were five (62.5%) phakic and three (37.5%) pseudophakic eyes preoperatively. Mean follow-up time was 9.1 ± 4.7 (1.5-14.5) months. Across all patients, mean FTMH diameter at the shortest and greatest widths were 529 ± 101 (404-661) and 1,189 ± 290 (829-1,656) µm, respectively. Mean best-corrected logarithm of the minimum angle of resolution visual acuity was 1.3 ± 0.23 preoperatively (approximately Snellen acuity 20/400) and 0.66 ± 0.40 postoperatively (approximately Snellen acuity 20/100) (P < 0.001). All FTMHs remained closed at all postoperative visits. CONCLUSION: The Texas Taco technique provided anatomical and functional improvement in challenging cases of large FTMHs without the need of additional surgical adjuvants.

Quarterly Anti-Vascular Endothelial Growth Factor Dosing for Neovascular Age-Related Macular Degeneration: Real-World Clinical Outcomes.

BACKGROUND AND OBJECTIVE: Characterize eyes managed with quarterly intravitreal anti-vascular endothelial growth factor injections for neovascular age-related macular degeneration (nAMD). PATIENTS AND METHODS: Treatment-naïve nAMD eyes managed predominately using a treat-and-extend approach that received five or more consecutive quarterly injections from 2005 to 2017. RESULTS: One hundred fifty eyes were retrospectively identified. During quarterly dosing, a mean of 9.8 injections were given over a mean of 29 months. Ninety-one eyes (61%) had no exudative disease recurrence during quarterly dosing. Thirty-three eyes (22%) experienced exudative activity recurrence, with a mean cumulative yearly recurrence rate of 12% and a mean 6-letter loss of visual acuity (VA). Twenty-four eyes (16%) stopped quarterly treatments; nine (38%) of these subsequently experienced exudative activity recurrence with a mean 8-letter VA loss. CONCLUSION: In this real-world analysis of nAMD managed with quarterly dosing over a mean of more than 2 years' follow-up, 22% experienced disease recurrence during quarterly dosing, and 38% of eyes that stopped quarterly dosing experienced subsequent exudative disease recurrence. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:e250-e256.].

Office-based intravitreal injection of expansile gas for management of macular hole in previously vitrectomized eyes.

PURPOSE: To report the successful closure of full-thickness macular hole (MH), using an office-based intravitreal gas injection, in two eyes having undergone prior pars plana vitrectomy (PPV). OBSERVATIONS: Patient 1 presented with acute loss of visual acuity to 20/300 in the left eye 5 months following PPV for fovea-off rhegmatogenous retinal detachment; MH was confirmed by examination and optical coherence tomography (OCT). 0.6 cc of 100% C3F8 gas was injected, with subsequent MH closure following one week of face-down positioning. Patient 2 presented with right eye visual acuity of 20/60 one month following PPV for optic nerve pit-associated maculopathy; MH was confirmed by examination and OCT. 0.85 cc of 100% C3F8 gas was injected in the office, with subsequent MH closure following one week of face-down positioning. CONCLUSIONS AND IMPORTANCE: MH management in previously vitrectomized eyes has traditionally been repeat PPV with internal limiting membrane peeling, fluid-air exchange, and expansile gas exchange. Intravitreal gas injection, in an office-based setting, is a viable clinical approach to close MH in some previously vitrectomized eyes.

Fovea-sparing rhegmatogenous retinal detachments: impact of clinical factors including time to surgery on visual and anatomic outcomes.

PURPOSE: Evaluate the impact of time to surgery and other clinical factors on visual and anatomic outcomes following surgical repair of fovea-sparing rhegmatogenous retinal detachments (RRD). METHODS: Visual and anatomic outcomes were analyzed for their association with clinical factors, including lens status, preoperative visual acuity (VA), contralateral RRD, RRD symptom duration, time to surgery, single-operation anatomic success, number of quadrants involved, posterior RRD extent, RRD extent closest to the fovea, number of retinal breaks, quadrants with retinal breaks, and surgery performed Saturday or Sunday versus Monday-Friday. RESULTS: Medical records of 423 eyes with fovea-sparing RRD repaired with pneumatic retinopexy (PR), scleral buckle (SB), pars plana vitrectomy (PPV), and PPV with SB (PPV/SB) were included. Sixty-seven percent and 89% were operated within 24 and 72 h of RRD presentation, respectively. Single-operation anatomic success rates were 59%, 89%, 84%, and 92% for PR, SB, PPV, and PPV/SB interventions, respectively. Final anatomic success was 100%. Three clinical factors correlated with faster time to surgery: shorter symptom duration (p < 0.02), RRD superior location (p = 0.001), and posterior extension into the macula (p = 0.01). The time to surgery did not correlate with visual or anatomic outcomes. Two clinical factors positively correlated with postoperative vision: preoperative VA (r > 0.25, p < 0.04) and single-operation anatomic success (p < 0.04). Surgeries performed on Monday through Friday (n = 411) were associated with better anatomic outcomes compared with the limited number performed on Saturday or Sunday (n = 12) (p = 0.005), although a greater proportion of operated cases over the weekend were PR. CONCLUSIONS: In the context of the current series, time to surgery did not correlate with visual or anatomic outcomes following the surgical repair of fovea-sparing RRDs. Preoperative VA and single-operation anatomic success correlated with improved visual outcome.

Targeted Retinal Photocoagulation for Diabetic Macular Edema with Peripheral Retinal Nonperfusion: Three-Year Randomized DAVE Trial.

PURPOSE: To evaluate the effect of targeted retinal photocoagulation (TRP) on visual and anatomic outcomes and treatment burden in eyes with diabetic macular edema (DME). DESIGN: Phase I/II prospective, randomized, controlled clinical trial. PARTICIPANTS: Forty eyes of 29 patients with center-involved macular edema secondary to diabetes mellitus. METHODS: Eyes with center-involved DME and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/32 and 20/320 (Snellen equivalent) were randomized 1:1 to monotherapy with 0.3 mg ranibizumab (Lucentis, Genentech, South San Francisco, CA) or combination therapy with 0.3 mg ranibizumab and TRP guided by widefield fluorescein angiography. All eyes received 4 monthly ranibizumab injections followed by monthly examinations and pro re nata (PRN) re-treatment through 36 months. Targeted retinal photocoagulation was administered outside the macula to areas of retinal capillary nonperfusion plus a 1-disc area margin in the combination therapy arm at week 1, with re-treatment at months 6, 18, and 25, if indicated. MAIN OUTCOME MEASURES: Mean change in ETDRS BCVA from baseline and number of intravitreal injections administered. RESULTS: At baseline, mean age was 55 years, mean BCVA was 20/63 (Snellen equivalent), and mean central retinal subfield thickness (CRT) was 530 µm. Thirty-four eyes (85%) completed month 36, at which point mean BCVA improved 13.9 and 8.2 letters (P = 0.20) and mean CRT improved 302 and 152 µm (P = 0.03) in the monotherapy and combination therapy arms, respectively. The mean number of injections administered through month 36 was 24.4 (range, 10-34) and 27.1 (range, 12-36), with 73% (362/496) and 80% (433/538) of PRN injections administered (P = 0.004) in the monotherapy and combination therapy arms, respectively. Goldmann visual field isopter III-4e area decreased by 2% and 18% in the monotherapy and combination therapy arms, respectively (P = 0.30). CONCLUSIONS: In this 3-year randomized trial of 40 eyes with DME, there was no evidence that combination therapy with ranibizumab and TRP improved visual outcomes or reduced treatment burden compared with ranibizumab alone.

THE ASSOCIATION OF EPIRETINAL MEMBRANE WITH MACULAR HOLE FORMATION AFTER RHEGMATOGENOUS RETINAL DETACHMENT REPAIR.

PURPOSE: To describe the clinical and optical coherence tomography findings associated with the development of full-thickness macular holes after rhegmatogenous retinal detachment (RRD) repair. METHODS: Retrospective, interventional case series. All patients who developed full-thickness macular holes after successful RRD repair from 3 clinical practices were reviewed. All cases of combined/simultaneous full-thickness macular hole and RRD were excluded. The main outcome measure was the presence of an epiretinal membrane at time of diagnosis of macular hole. RESULTS: Twenty-five full-thickness macular holes were diagnosed after successful retinal detachment repair. Surgical approach to RRD repair included pneumatic retinopexy (6, 24%), scleral buckle alone (5, 20%), pars plana vitrectomy only (8, 32%), and combined scleral buckle and pars plana vitrectomy (6, 24%). The preceding RRD involved the macula in 19 patients (76%) before the formation of the macular hole. The median time to full-thickness macular hole diagnosis after RRD repair was 63 days (range, 4-4,080 days). An epiretinal membrane was present in all 25 (100%) macular holes. Two macular holes (8%) spontaneously closed, whereas the other 23 (92%) were successfully closed with a single surgical procedure. Mean visual acuity improved by approximately 5 lines to 20/72 (range, 20/20 to counting fingers at 1 foot) from 20/240 (range, 20/30 to hand motions) after macular hole repair (P < 0.0001). CONCLUSION: Full-thickness macular hole formation can occur after all types of RRD repair and is associated with an epiretinal membrane. The epiretinal membrane may play a role in the pathogenesis of secondary macular hole formation after RRD repair.

Histopathologic Analysis of Transvitreal Fine Needle Aspiration Biopsy Needle Tracts for Uveal Melanoma.

PURPOSE: Perform the first in vivo examination of fine needle aspiration biopsy (FNAB) scleral tracts to determine the incidence of iatrogenic extension of tumor cells. DESIGN: A prospective, consecutive, observational case series. METHODS: This study was performed in a clinical/surgical setting at Retina Consultants of Houston and Houston Methodist Hospital, Houston, Texas, and included 10 patients who were scheduled for enucleation as primary treatment for uveal melanoma. Treatment included FNAB, enucleation, and histopathologic analysis. The primary outcomes were tumor location and dimension as identified by B-scans and histopathologic analysis. Tumor type was classified by gene expression profile and American Joint Committee on Cancer staging. Twenty-five- or 27-gauge needles were used for FNAB under direct visualization. Cell blocks of acquired specimens were examined using hematoxylin-eosin stain and double immunostain using HMB45 with red chromogen and Ki67 with brown 3,3'-diaminobenzidine chromogen. RESULTS: Mean follow-up after enucleation was 20.4 months (range 9.9-31.7). All biopsy specimens had adequate yields for genomic analysis. No enucleation specimen contained tumor cells within sclera, pars plana, or pars plicata. One specimen contained a small collection of tumor cells within the anterior vitreous in the quadrant of the biopsy site. No patient developed an orbital recurrence. Four patients developed nonorbital metastatic uveal melanoma during the study period. Three of them died, and 1 is alive with hepatic metastasis. CONCLUSIONS: No iatrogenic extension of tumor was reported. FNAB is a safe procedure that produces a high cellular yield for cytologic and genomic analyses with minimal risk of extraocular dissemination.

ENDOPHTHALMITIS AFTER INTRAVITREAL INJECTION: Role of Prophylactic Topical Ophthalmic Antibiotics.

PURPOSE: To determine the rate of postintravitreal injection endophthalmitis and to assess microbiological features and outcomes with and without the use of peri-intravitreal injection topical ophthalmic antibiotics. METHODS: Consecutive series of endophthalmitis cases retrospectively identified after intravitreal injection at a multicenter, retina-only referral practice (Retina Consultants of Houston) from January 1, 2011 to December 31, 2014. Prophylactic peri-intravitreal injection topical antibiotics were routinely used during the initial 12-month period (January 1, 2011-December 31, 2011) and not used in the final 24-month period (January 1, 2013-December 31, 2014). Main outcome measures were incidence of endophthalmitis, microbiology results, treatment strategies, and visual outcomes. RESULTS: Of 90,339 intravitreal injections, 30 cases of endophthalmitis were identified (endophthalmitis rate = 0.033%; 95% confidence interval, 0.021-0.045%; or approximately 1 of 3,011 intravitreal injections). The most common organisms isolated were coagulase-negative staphylococci (n = 10, 33%), followed by Streptococcus mitis (n = 2, 7%). Fourteen cases (47%) were culture negative. Peri-intravitreal injection topical antibiotic prophylaxis did not decrease the rate of endophthalmitis (0.035% [95% CI, 0.007-0.064%] with antibiotic use versus 0.021% [95% CI, 0.008-0.033%] without antibiotic use; P = 0.261). CONCLUSION: The risk of endophthalmitis after intravitreal injection remains low, with coagulase-negative staphylococci and Streptococcus mitis the most common bacterial isolates identified. Prophylactic peri-intravitreal injection topical ophthalmic antibiotic use did not decrease the endophthalmitis rate.

Progressive retinal nonperfusion in ischemic central retinal vein occlusion.

BACKGROUND: Serial wide-field fluorescein angiography was performed on eyes with preproliferative (ischemic) central retinal vein occlusion to evaluate retinal perfusion. METHODS: Serial wide-field fluorescein angiography was performed on 12 preproliferative central retinal vein occlusion eyes in the 3-year Rubeosis Anti-VEGF (RAVE) trial using the Staurenghi lens (Ocular Staurenghi 230SLO Retina Lens) with a scanning laser ophthalmoscope (Heidelberg HRA Spectralis). "Disk area" was defined anatomically for each eye. RESULTS: Mean total field of gradable retina was 290 disk areas (range, 178-452). All eyes demonstrated extensive areas of retinal nonperfusion; at baseline, mean area of retinal perfusion was 106 disk areas (range, 37-129), correlating with a mean of 46.5% perfused retinal area (range, 19.1-56.4%). The area of retinal nonperfusion increased in all eyes with a mean loss of approximately 8.1% of perfused retinal area per year (range, 4.3-12.4%), which corresponded to a mean 15-disk areas (range, 12-35) of retina evolving from perfused to nonperfused annually. The extent of baseline and final nonperfusion was not significantly different between eyes that developed neovascularization and eyes that did not. CONCLUSION: In this population of severe central retinal vein occlusion eyes, profound retinal nonperfusion was observed with wide-field fluorescein angiography at baseline and the extent of nonperfusion progressed while undergoing anti-vascular endothelial growth factor therapy.

Ranibizumab in preproliferative (ischemic) central retinal vein occlusion: the rubeosis anti-VEGF (RAVE) trial.

PURPOSE: To analyze the efficacy and safety of ranibizumab in eyes with preproliferative (ischemic) central retinal vein occlusion. METHODS: In this prospective, phase I/II, open-label clinical trial, eyes at high risk of neovascular complications were identified; all eyes met ≥ 3 of 4 high-risk criteria: 1) the best-corrected visual acuity being ≤ 20/200, 2) loss of the 1-2e isopter on Goldmann visual field, 3) relative afferent pupillary defect being ≥ 0.9 log units, and 4) electroretinogram B-wave reduction to ≤ 60% of the corresponding A-wave. Monthly intravitreal ranibizumab treatment for 9 months, monthly monitoring for 3 months, and then monthly examination with pro re nata retreatment on evidence of disease activity for 24 months were performed. Therefore, the total study duration was 36 months. RESULTS: The main outcome measures were mean change in the best-corrected visual acuity and central macular thickness by optical coherence tomography, proportion of patients with neovascular complications, and the incidence and severity of ocular and nonocular adverse events. Twenty patients were enrolled in the Rubeosis Anti-VEgf trial, and the mean number of intravitreal treatments administered through Months 24 and 36 were 14.1 and 17.2, respectively. The mean best-corrected visual acuity letters gained were +21.1 and +21.4 at 9 and 36 months, respectively. The mean central macular thickness improved -294 µm from baseline after 9 monthly treatments. Subsequently, after 3 months of observation, the mean central macular thickness increased +203 µm. On initiation of pro re nata ranibizumab retreatment, the mean central macular thickness then improved -191 µm at Month 36 compared with Month 12. Nine patients developed neovascular complications, being diagnosed after a mean of 24-month follow-up (range, 3-44 months), with 2 patients developing neovascularization after completion of the 36-month trial endpoint (at Months 42 and 44 after study enrollment). CONCLUSION: Intravitreal ranibizumab therapy can improve retinal anatomy and vision in eyes with severe central retinal vein occlusion. Despite significant clinical benefit with antivascular endothelial growth factor therapy, the risk of neovascular complications was not ameliorated by vascular endothelial growth factor blockade, but was merely delayed.

SAVE (Super-dose anti-VEGF) trial: 2.0 mg ranibizumab for recalcitrant neovascular age-related macular degeneration: 1-year results.

OBJECTIVES: To assess durability of visual and anatomic gains with 2.0 mg ranibizumab in recalcitrant neovascular age-related macular degeneration (AMD). METHODS: Phase I-II trial of 88 patients with recalcitrant neovascular AMD treated as needed every 4 (cohort A) or 6 weeks (cohort B) following three monthly doses. ETDRS refraction and spectral-domain OCT-guided as-needed re-treatments. RESULTS: Seventy-nine patients completed the 12-month endpoint and were given 11.6 (cohort A) and 8.6 (cohort B) mean treatments. Mean best corrected visual acuity gains of 4.1 letters following three monthly doses were sustained for 12 months for both cohorts. Anatomic improvements were sustained for 12 months for cohort A, but not for cohort B; cohort B demonstrated a gradual increase in mean central retinal thickness (P = .03). CONCLUSION: Visual and anatomic gains achieved with 2.0 mg ranibizumab in recalcitrant neovascular AMD were sustained for 1 year with monthly treatment. In comparison, anatomic gains were diminished with less than monthly treatment.