A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema
To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema \- Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months). Stage 2 (select sites): 75 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of Luminate intravitreal injection or Avastin intravitreal injection (0.5 mg and 1.0 mg). Subjects will be followed monthly for 20 weeks (5 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
218
Associated Retina Consultants
Phoenix, Arizona, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Change in BCVA at Week 24
Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Time frame: Value of 24 Weeks minus baseline value
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Northern California Retina Vitreous Associates
Mountain View, California, United States
West Coast Retina
San Francisco, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
New England Retina Associates
New London, Connecticut, United States
Florida Eye Clinic
Altamonte Springs, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Wilmer Eye Institute at John Hopkins University
Baltimore, Maryland, United States
...and 7 more locations