Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study).

PURPOSE: To assess generalized (GD) and focal ellipsoid zone disruption (FD) in patients with symptomatic vitreomacular adhesion (sVMA) using spectral domain optical coherence tomography (SD-OCT) following ocriplasmin. PATIENTS AND METHODS: OZONE was a Phase 4, retrospective study of patients with sVMA treated with a single intravitreal injection of ocriplasmin (0.125 mg). Data from adult patients with at least 6-month follow-up after ocriplasmin were included. SD-OCT was performed at baseline (within 30 days before ocriplasmin), before Day 21 post-injection (early observation, EO), and by last observation (LO) which was maximally 6 months post-injection. The main outcome measure was the development of new and the evolution of existing FD/GD at EO and LO. RESULTS: The study enrolled 134 eyes/patients from 22 sites in the USA. At baseline, 87 eyes (64.9%) had FD, 21 eyes (15.7%) had GD and 26 eyes (19.4%) had no FD/GD. Among the eyes without FD/GD at baseline, 13 (50%) and 8 (30.8%) developed FD or GD, respectively, by EO. By LO, FD/GD improvement or resolution was seen in >80% of these eyes. Among the eyes with FD/GD at baseline, <40% had improving/resolving EZ integrity at LO. The absence of FD/GD at baseline was associated with less persistent FD/GD at LO (P<0.0005). The presence of FD with MH at baseline was associated with persistent FD at LO (P=0.027). CONCLUSION: The fact that a large majority of eyes had FD/GD prior to ocriplasmin was unexpected and demonstrates that EZ disruptions are common in sVMA. This suggests that loss of EZ integrity may be part of the natural history of this disorder. It is hypothesized that the status of the EZ at baseline is a contributing, ocriplasmin independent modulator of subsequent EZ changes after ocriplasmin. Prospective analyses which include a sham control group would be required to test this hypothesis.

Ocriplasmin Treatment Leads to Symptomatic Vitreomacular Adhesion/Vitreomacular Traction Resolution in the Real-World Setting: The Phase IV ORBIT Study.

PURPOSE: To evaluate clinical outcomes and safety up to 12 months after ocriplasmin injection for the treatment of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) in a real-world setting. DESIGN: The Phase IV Ocriplasmin Research to Better Inform Treatment (ORBIT) trial (NCT02079883) was a Phase IV multicenter, prospective, observational study. PARTICIPANTS: Patients aged ≥18 years with symptomatic VMA/VMT treated with ocriplasmin. METHODS: Patients received a single 0.125 mg intravitreal injection of ocriplasmin. All assessments and treatment decisions were at the discretion of the treating physician. Spectral-domain OCT (SD-OCT) images were analyzed by an independent central reading center (CRC). All enrolled patients were included in demographic, baseline characteristics, and safety analyses. Patients with symptomatic VMA/VMT at baseline determined by CRC were included in baseline ocular characteristics and efficacy analyses. MAIN OUTCOME MEASURES: Clinical outcomes were measured up to 12 months and included resolution of symptomatic VMA, closure of full-thickness macular hole (FTMH), mean change from baseline in best-corrected visual acuity (BCVA), incidence of vitrectomy, and time to first vitrectomy. Safety outcomes included the incidence and timing of onset of adverse drug reactions (ADRs). RESULTS: Of the 539 patients enrolled, 480 were determined to have symptomatic VMA/VMT at baseline post-CRC assessment. After treatment with ocriplasmin, the rate of VMA/VMT resolution was 45.8% (95% confidence interval [CI], 41.3-50.4) at month 1 and 59% (95% CI, 54.4-63.4) at months 10 to 12. The rate of FTMH closure was 30.5% (95% CI, 22.4-39.7) at month 1 and 32.2% (95% CI, 23.9-41.4) at months 10 to 12. Mean (standard deviation) change from baseline in BCVA was 1.5 (11.19) letters at month 1 and 5.2 (13.60) letters at months 10 to 12. Vitrectomy was performed in 28.5% of patients, with a median time to vitrectomy of 63 days. Adverse drug reactions were reported by 30.6% of patients; 5.2% experienced a serious ADR. CONCLUSIONS: Results from the ORBIT study demonstrate that treatment with ocriplasmin is effective and well tolerated in patients with symptomatic VMA/VMT in a real-world setting. The percentage of patients with VMA/VMT resolution at month 1 was higher than previously reported in well-controlled clinical trials. No new safety signals were identified.

Ocular syphilis in patients with Human Immunodeficiency Virus infection.

As Acquired Immunodeficiency Disease (AIDS) turns thirty-years old, much progress has been made. 56,000 new cases of the Human Immunodeficiency Virus (HIV) infection are expected in Americans this year. At least half or more will be in African Americans. Reports of the association between syphilis and HIV infection are well documented. We present a case of bilateral optic neuritis and panuveitis as the initial presentation in a previously undiagnosed patient with human immunodeficiency virus (HIV) and syphilis.

Diabetic retinopathy: current concepts and emerging therapy.

More Americans become blind each year from microvascular complications of diabetes than from any other cause. Several studies have indicated that tight glucose control and lifestyle modification can dramatically reduce the incidence and prevalence of diabetic retinopathy. Research over the past several years has yielded a tremendous increase in our knowledge of the pathogenesis of the damage to the retina that occurs in diabetes and has facilitated our ability to intervene and control the damage. New intravitreal medical therapies supported by government- and industry-supported research are gradually replacing standard laser photocoagulation for the treatment of all forms of retinopathy.

Reversible hyperglycemic homonymous hemianopia.

We report a 67-year-old female diabetic with homonymous hemianopia as the presenting sign of nonketotic hyperglycemia. Magnetic resonance imaging (MRI) was abnormal with diffuse bilateral hyperintense white matter changes. A follow-up MRI scan 15 years later showed persisting abnormality. Her hemianopic visual field loss was reversed after correction of her hyperglycemia. Diabetes mellitus should be considered with the sudden onset of a homonymous hemianopia.

Lateral rectus muscle palsy, facial numbness and ataxia as the initial manifestation of multiple sclerosis.

Lateral rectus muscle (LRM) palsy due to a nuclear or fascicular sixth nerve lesion is rare as the presenting sign of multiple sclerosis (MS). It is more common to find this palsy in the company of other nearby cranial nerves deficits. Facial numbness in association with a LRM palsy or paresis may go unappreciated and therefore underreported. We report an unusual patient with a LRM palsy, facial anesthesia, ataxia and as the initial manifestation of MS. There was a demyelinating lesion in the pons seen on magnetic resonance imaging (MRI).