Integrin peptide inhibitor for the treatment of intermediate Age Related Macular Degeneration

Abstract

Purpose : Purpose
Luminate^® is a first-in-class integrin-inhibitor and has been shown to have treatment effects for both vitreolysis and angiogenesis. To date, more than 400 subjects with DME and VMT have been treated by intravitreal treatment with positive efficacy and an excellent safety profile. Proteomics and genomic testing at Caltech has suggested a potential neuroprotective effect which could treat other retinal diseases. The purpose of this probe study was to evaluate any possible effect of Luminate^® on patients with intermediate dry AMD.

Methods : Methods
This case series was IRB approved and required signed informed consent. This was a prospective, interventional, case series. Main inclusion criteria involved dry macular degeneration eyes with relatively intact photoreceptor and RPE layers in the central 1mm by OCT. Baseline BCVA was between 20/30 and 20/200 with no evidence of subretinal fluid or CNV and no history of anti-VEGF treatment. All recruited patients underwent a baseline single intravitreal injection of Luminate® 1.0 mg and were monitored monthly over a 6-month follow-up. A central macular thickness OCT, digital color photos and BCVA pre and post treatment were obtained.

Results : Results.
A total of 5 patients (five eyes) were included in this probe study. All 5 patients completed a minimal 3-month follow-up. Results obtained were as follows: In patient 1, BCVA improved form 0.5 to 0.3 logMAR; patient 2 improved from 1.0 to 0.6 logMAR; patient 3 improved from 1.3 to 1.0 logMAR and patient 4 improved from 0.2 to 0.1 logMAR respectively. Mean BCVA changed from 0.75 ± 0.52 (~20/100) at baseline to 0.66 ± 0.4 (~20/60) logMAR at 3-month examination.
One patient (patient 5) did not experience a change in visual acuity. All five patients subjectively reported more vivid colors and brighter images in their vision. There was a tendency for BCVA improvement.

Conclusions : Conclusions
In a small pilot study, Luminate® increased BCVA in four of five eyes with intermediate dry AMD. This is the first clinical study showing improvement in BCVA by intravitreal Luminate therapy. Future studies with larger cohorts of study subjects and double masked controls is warranted. In future studies, objective anatomic analysis of drusen, auto-fluorescence, and multifocal ERGs would also provide useful guidance on study design and treatment.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.