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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Age-related Macular Degeneration

In brief

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

Key facts

Study ID

NCT03626636

Run by

Allegro Ophthalmics, LLC

People needed

42

Starts

2017-08-01

Expected to finish

2019-04-04

Last updated by the study team

2020-07-08

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Derek Kunimoto — Gilbert, Arizona, United States
• Derek Kunimoto — Phoenix, Arizona, United States
• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Florida Eye Clinic — Altamonte Springs, Florida, United States
• Raj Maturi — Indianapolis, Indiana, United States
• Valley Retina Institute — McAllen, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.