Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema (DEGAS)
Phase 2
- Registration Number
- CTRI/2009/091/000281
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
Ages Eligible for Study: 18 Years and older,
Genders Eligible for Study: Both,
Accepts Healthy Volunteers: No,
Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye.
Exclusion Criteria
Proliferative Diabetic Retinopathy in the Study Eye. Subjects Receiving Concomitant Intravitreal Anti-VEGF Therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Change from Baseline in the Best Corrected Visual Acuity ScoreTimepoint: Month 24
- Secondary Outcome Measures
Name Time Method 1.Mean Changes in NEI-VFQ-25 Composite Score from BaselineTimepoint: Month 36;2.Plasma Concentration of PF-04523655Timepoint: Week 1;3.Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from BaselineTimepoint: Month 24, 36;4.Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic ExaminationTimepoint: Month 24, 36;5.Mean Change from Baseline in the Best Corrected Visual Acuity ScoreTimepoint: Month 36;6.Mean Changes in Area of Fluorescein Leakage from BaselineTimepoint: Month 24, 36;7.Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from BaselineTimepoint: Month 24, 36;8.Mean Changes in Retinal Thickness from BaselineTimepoint: Month 24, 36;9.Mean Changes in Macular Volume from BaselineTimepoint: Month 24, 36