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:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - 85
Updated:3/13/2019
Start Date:August 1, 2017
End Date:June 28, 2019

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A Randomized Controlled, Double-Masked, Crossover 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

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

Approximately 40 eligible subjects who have been diagnosed with intermediate Non-Exudative
AMD, that require treatment will be enrolled and randomized (1.7:1) to one of 2 treatment
groups:

Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected
intravitreally with 1.0mg of Luminate® Treatment Group 2: 15 Non-Exudative AMD subjects with
BCVA of 20/40 - 20/200 will be treated with a sham injection

At the 16-week visit, the study will be unmasked to the sponsor and injecting investigator
(observing investigators will remain masked). Subjects in the treatment group will receive a
2nd dose of Luminate®. Subjects in the control group will be offered the opportunity to
crossover to treatment with a single dose of Luminate®.

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
We found this trial at
7
sites
McAllen, Texas 78503
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Altamonte Springs, Florida 32701
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Altamonte Springs, FL
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Beverly Hills, California 90211
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Beverly Hills, CA
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Gilbert, Arizona 85014
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Gilbert, AZ
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Indianapolis, Indiana
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Indianapolis, IN
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Phoenix, Arizona 85014
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Phoenix, AZ
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San Antonio, Texas 78240
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San Antonio, TX
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