A Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration

• Status: Completed
• Trial end date: 2019-04-04
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allegro Ophthalmics, LLC

Criteria

Inclusion Criteria:

• Male or female patients, 50 to 85 years of age at screening visit

• Subject has signed the Informed Consent form

• Subjects with Non-Exudative AMD having ETDRS BCVA between 33 and 72 letters read (equivalent to 20/40 - 20/200 on Snellen Chart) with the level of vision caused by the non-exudative AMD and no other factor/s

• Subjects with symptomatic decrease in visual acuity in the last 12 months

• Subjects with combination of areas of RPE disturbances (hyper or hypopigmentation) and/or > 1 large druse(n) (>125 microns) and/or multiple intermediate drusen (62-124 microns) in the macula as confirmed by the central reading center

• Subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonable reasonably well- preserved central 1 mm of the macula means:

• The RPE and outer retinal layers throughout the central 1 mm are intact

• No signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material

• No serous pigment epithelium detachments >100 microns in height

Exclusion Criteria:

• Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug.

• Participation in an investigational drug or device study within 90 days of screening

• Subjects with active exudative AMD in the fellow eye

• Subjects who had anti-VEGF IVT in either eye in the past 90 days

• Subjects with pigment epithelium detachments

• Subjects with active exudative AMD

• Subjects with any prior retina surgery

• Subjects with pathology that could prevent observation and follow-up of macular structures and measurement of BCVA (i.e. advanced primary open angle glaucoma, any stage of normal tension glaucoma and corneal opacification)

• Subjects that are likely to require cataract surgery in the opinion of the investigator within the study protocol period