Intravitreal ranibizumab for the treatment of choroidal neovascularizations associated with pathologic myopia: a prospective study.

PURPOSE: It was the aim of this study to determine the efficacy of intravitreal ranibizumab as treatment of choroidal neovascularizations associated with pathologic myopia. MATERIALS AND METHODS: In an uncontrolled, prospective time series cohort study, 65 eyes of 64 consecutive patients with choroidal neovascularization associated with pathologic myopia were treated with intravitreal ranibizumab and observed over 12 months. The change in best-corrected visual acuity (BCVA) at 6 and 12 months served as primary end point. Safety, central retinal thickness, neovascularization activity on fluorescein angiography and the number of ranibizumab injections were secondary end points. RESULTS: BCVA improved significantly throughout the follow-up (p = 0.001). The mean BCVA was 0.2 at baseline (SD 0.13) and 0.4 at 12 months (SD 0.21). Improvement was strongest within the first 3 months (p = 0.0001). The mean central retinal thickness showed a reduction from 313 µm (SD 82) to 243.5 µm (SD 31; p = 0.0001). CONCLUSION: Intravitreal ranibizumab offers a safe and effective treatment for choroidal neovascularizations in pathologic myopia.

Intravitreal aflibercept for choroidal neovascularization associated with chorioretinitis: a pilot study.

PURPOSE: The purpose of this study was to evaluate the potential benefits of intravitreal aflibercept injections for the treatment of choroidal neovascularization (CNV) secondary to chorioretinitis. METHODS: In this uncontrolled, prospective cohort study, 15 eyes of 14 consecutive patients affected by CNV associated with ocular toxoplasmosis were treated with intravitreal aflibercept (2 mg) pro re nata and observed over a 12-month follow-up period. The primary outcome was the change in best-corrected visual acuity (BCVA) from baseline to month 12. Secondary outcomes included change in central retinal thickness (CRT) in the foveal area on optical coherence tomography (OCT) from baseline to month 12, the number of intravitreal aflibercept injections administered, and safety. RESULTS: Mean (standard deviation [SD]) BCVA improved significantly from 0.36 (0.23) at baseline to 0.64 (0.3) at month 12 (P=0.0002). Mean (SD) CRT on OCT showed a reduction from 317 (74) µm at baseline to 254 (43) µm (P=0.0002) at month 12. A mean (SD) of 1.7 (0.5) injections (range, 1-2 injections) were performed during the study period. No cases of endophthalmitis, uveitis, stroke, or retinal detachment were noted. No patient demonstrated an intraocular pressure >20 mmHg at any study visit. CONCLUSION: Intravitreal aflibercept showed a positive clinical effect and was well tolerated for the treatment of CNV associated with chorioretinitis. The results could be helpful for selecting a treatment for CNV secondary to chorioretinitis.

Intravitreal aflibercept for the treatment of choroidal neovascularization associated with pathologic myopia: a pilot study.

PURPOSE: To determine the efficacy of intravitreal aflibercept injections for the treatment of patients with choroidal neovascularization (CNV) associated with pathologic myopia. METHODS: In this uncontrolled, prospective cohort study, 31 eyes of 30 consecutive patients affected by CNV associated with pathologic myopia were treated with intravitreal aflibercept (2 mg) as needed following two initial monthly doses and observed over a 12-month follow-up period. The primary endpoint was change in best-corrected visual acuity (BCVA) at month 12, while central retinal thickness (CRT) on optical coherence tomography (OCT), neovascularization activity on fluorescein angiography, the number of aflibercept injections administered, and safety were examined as secondary endpoints. RESULTS: Patients received a mean of 2.6 intravitreal aflibercept injections over the 12-month study period. Compared with baseline, BCVA improved significantly at all time points (P<0.05). Mean (standard deviation [SD]) decimal BCVA was 0.2 (0.1) at baseline and 0.35 (0.16) at month 12. The greatest improvement in BCVA was seen within the first 2 months (P=0.01). Mean (SD) CRT on OCT decreased from 285 (62) µm at baseline to 227 (42) µm (P=0.01) at month 12. There was a continuous decrease in mean CRT on OCT over time. No cases of endophthalmitis, uveitis, stroke, or retinal detachment were noted. No patient demonstrated an intraocular pressure >20 mmHg during any study visit. CONCLUSION: The 12-month results of intravitreal aflibercept for myopic CNV using an as-needed regimen were positive, showing benefits in visual and anatomic outcomes and an acceptable tolerability profile.

Results of a Multicenter, Randomized, Double-Masked, Placebo-Controlled Clinical Study of the Efficacy and Safety of Visomitin Eye Drops in Patients with Dry Eye Syndrome.

INTRODUCTION: This article presents the results of an international, multicenter, randomized, double-masked, placebo-controlled clinical study of Visomitin (Mitotech LLC, Moscow, Russian Federation) eye drops in patients with dry eye syndrome (DES). Visomitin is the first registered (in Russia) drug with a mitochondria-targeted antioxidant (SkQ1) as the active ingredient. METHODS: In this multicenter (10 sites) study of 240 subjects with DES, study drug (Visomitin or placebo) was self-administered three times daily (TID) for 6 weeks, followed by a 6-week follow-up period. Seven in-office study visits occurred every 2 weeks during both the treatment and follow-up periods. Efficacy measures included Schirmer's test, tear break-up time, fluorescein staining, meniscus height, and visual acuity. Safety measures included adverse events, slit lamp biomicroscopy, tonometry, blood pressure, and heart rate. Tolerability was also evaluated. RESULTS: This clinical study showed the effectiveness of Visomitin eye drops in the treatment of signs and symptoms of DES compared with placebo. The study showed that a 6-week course of TID topical instillation of Visomitin significantly improved the functional state of the cornea; Visomitin increased tear film stability and reduced corneal damage. Significant reduction of dry eye symptoms (such as dryness, burning, grittiness, and blurred vision) was also observed. CONCLUSION: Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage. FUNDING: Mitotech LLC.