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 |
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
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®.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials