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RETROSPECTIVE STUDY: L-DOPA WAS PROTECTIVE AGAINST WET AMD

Exogenous L-DOPA appeared to protect against the development of wet age-related macular degeneration (AMD) in multiple cohorts of patients, according to a retrospective study published in the American Journal of Medicine.1

Researchers analyzed medical records to compare the incidence of AMD in patients taking L-DOPA and those not taking L-DOPA. Three cohorts of patients were analyzed: two separate cohorts from the Marshfield Clinic in Wisconsin (n = 17 000 and n = 20 000) and one from the Truven MarketScan databases (n = 87 million).

For patients not taking L-DOPA, the average age of AMD diagnosis was approximately 71.3 years in all three groups. This was a significantly earlier onset than patients taking L-DOPA, who were diagnosed with AMD at an average age of 79.4 years.

1. Brilliant MH, Viziri K, Connor TB, et al. Mining retrospective data for virtual prospective drug repurposing: L-DOPA and age-related macular degeneration [published online ahead of print October 30, 2015]. Am J Med.

Delayed Rod-Mediated Dark Adaptation Linked With Doubled Risk of AMD

Patients with delayed rod-mediated dark adaptation were nearly twice as likely as patients with normal dark adaptation to develop AMD by 3 years after initial testing, according to a study published in Ophthalmology.1

Baseline and follow-up visits were completed by 325 patients with stage 1 normal vision as defined by the AREDS AMD classification system. Approximately 81% of participants had normal rod-mediated dark adaptation.

After adjusting for age and smoking status, patients with rod-mediated abnormal dark adaptation were approximately twice as likely to have AMD at follow-up year 3 compared with patients with normal rod-mediated dark adaptation.

“The biological relevance of this test is high,” the study authors wrote, “because it assesses translocation of vitamin A derivatives across the retinal pigment epithelium and Bruch’s membrane, two tissues with prominent age- and AMD-related pathology.”

1. Owsley C, McGwin G, Clark ME, et al. Delayed rod-mediated dark adaptation is a functional biomarker for incident early age-related macular degeneration [published online ahead of print October 30, 2015]. Ophthalmology.

Dexamethasone Implant, Given at 6-Month Intervals, Sustained Improvement for 3 Years

The dexamethasone intravitreal implant (Ozurdex, Allergan) produced sustained retinal structural improvement in patients with diabetic macular edema (DME) when administered in doses of 0.7 mg or 0.35 mg at 6-month intervals, according to a study published in the British Journal of Ophthalmology.1

Researchers analyzed data from two multicenter, masked, phase 3 studies with identical protocols. Patients in those studies were randomly assigned to receive treatment with the dexamethasone intravitreal implant 0.7 mg or 0.35 mg or sham. Entry criteria included DME diagnosis, BCVA of 34 to 68 ETDRS letters, and central subfield retinal thickness of at least 300 µm. Patients were followed for 3 years and treated at intervals of at least 6 months.

After 3 years, eyes in the treatment group showed mean improvement in macular edema grade compared with eyes in the sham group (P < .05). Eyes in the 0.7-mg group showed mean delayed time to onset of two-step progression in diabetic retinopathy severity by approximately 12 months.

1. Danis RP, Sadda S, Li XY, et al. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials [published online ahead of print November 18, 2015]. Br J Ophthalmol.

Fluocinolone Acetonide Implant Met Primary Phase 3 Endpoint for Noninfectious Posterior Uveitis

Treatment of noninfectious posterior uveitis with a fluocinolone acetonide implant (Medidur, pSivida) prevented disease recurrence at a higher rate than sham injection, thus meeting the primary endpoint in a phase 3 clinical trial, according to a company press release.

Researchers in a phase 3 multicenter, double-masked trial randomly assigned patients to treatment (n = 87) or sham (n = 42). At 6 months, more patients in the sham group (78.6%) showed disease recurrence than in the treatment group (18.4%; P < .001).

In the treatment group, 27.6% of treated eyes showed an increase of intraocular pressure (IOP) to greater than 21 mm Hg, compared with 16.7% in the control group. Through 6 months, 2.3% of eyes in the treatment group required incisional surgery to reduce IOP, and no control eyes required such surgery. Of 64 eyes phakic at baseline, 9.5% of eyes in the treatment group required cataract surgery, and 4.8% of eyes in the control group required cataract surgery.

Suprachoroidal Space TA Formulation Advances in Clinical Trials

A proprietary form of triamcinolone acetonide for injection into the suprachoroidal space (CLA-TA; Clearside Biomedical) for the treatment of noninfectious uveitis met primary and secondary endpoints in the Dogwood clinical trial, according to a company press release of top-line data. Clearside also announced updates on the enrollment status of the Peachtree and Tanzanite trials, both of which will assess the safety and efficacy of CLA-TA in ocular diseases.

In the Dogwood trial, a single suprachoroidal microinjection of CLA-TA resulted in reduction of central subfield thickness (P = .0018) and mean improvement from baseline in BCVA (P = .0004) at 8 weeks. There were no serious adverse events related to the treatment in the trial, including no increases in IOP.

The Peachtree trial, a phase 3 trial assessing CLA-TA in the suprachoroidal space for the treatment of macular edema associated with noninfectious uveitis, has enrolled its first patient. The Tanzanite trial, a phase 2 clinical trial assessing the safety and efficacy of CLS-TA in the suprachoroidal space combined with intravitreal aflibercept (Eylea, Regeneron) for treatment of macular edema associated with retinal vein occlusion, has completed enrollment.

Phase 2 Gene Therapy Trial Begins Enrollment

A phase 2 clinical trial assessing the safety and efficacy of a gene therapy approach to treatment of choroideremia has begun enrolling patients at the University of Miami Miller School of Medicine.

Researchers will deliver a wild-type copy of the Rab-escort protein 1 (REP1) gene using an adeno-associated virus (AAV2-REP1). The open-label study will enroll six male patients, each of whom will receive a single dose of AAV2-REP1 via subretinal injection.

Choroideremia, an X-linked recessive disease, is caused by mutations to genes that encode REP1. The disease, for which no treatment currently exists, affects 1 in 50 000 people.

Phase 2b DME Trial Completes Enrollment

A phase 2b trial assessing the safety and efficacy of ALG-1001 (Luminate, Allegro) as DME therapy has completed enrollment. The company expects to report top-line data by the third quarter of 2016.

DEL MAR is a double-masked, placebo-controlled, multicenter 6-month phase 2b trial evaluating the safety and efficacy of intravitreal ALG-1001 compared with bevacizumab (Avastin, Genentech) in patients with DME. In the trial, 120 patients will be randomly assigned to receive one of three doses of ALG-1001 (1.0 mg, 2.0 mg, or 3.0 mg) or bevacizumab.

Widefield Imaging Device Cleared for Use in Infants

The US Food and Drug Administration has granted clearance to the PanoCam LT Widefield Imaging System (Visunex) for the imaging of all newborn infants.

The device is a compact, wireless imaging system designed to detect a number of external, anterior, and posterior segment vision disorders.

Preliminary Data: Anti-VEGF Eyedrop for Wet AMD Treatment Showed No Safety Concerns

No treatment-related adverse events have been reported in a phase 1/2 study evaluating the anti-VEGF eyedrop PAN-90806 (PanOptica) for the treatment of neovascular AMD. Anti-VEGF biological activity was observed in all monotherapy dose arms of the study. A full data set will be available in 2016.

According to the company’s president and CEO, Paul Chaney, PanOptica is developing an advanced, next-generation formulation of PAN-90806 for use in future trials. Mr. Chaney also reported that the company has initiated a phase 1 trial of PAN-90806 in patients with proliferative diabetic retinopathy.

First Retina World Congress Will Convene in Spring 2017

The inaugural Retina World Congress will be held February 23 to 26, 2017, in Fort Lauderdale, Fla., the meeting’s organizers announced.

The proceedings of the meeting will be published in The International Journal of Retina and Vitreous. Rishi P. Singh, MD, will serve as president of the Retina World Congress. n

 

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About Retina Today

Retina Today is a publication that delivers the latest research and clinical developments from areas such as medical retina, retinal surgery, vitreous, diabetes, retinal imaging, posterior segment oncology and ocular trauma. Each issue provides insight from well-respected specialists on cutting-edge therapies and surgical techniques that are currently in use and on the horizon.