Phase 3
Completed N=284
A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
Source: ClinicalTrials.gov NCT02121262 ↗Enrolled (actual)
284
Serious AEs
20.4%
Results posted
Nov 2020
Primary outcomePrimary: Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye — 1.4; 4.3 letters — p=0.0011
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye |
1.4; 4.3 | 0.0011 sig |
| SECONDARY Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye |
10.2; 11.7 | 0.7431 |
| SECONDARY Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye |
-120.3; -209.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Total Macular Leakage Area by FA in the Study Eye |
-0.637; -8.367 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Presence of macular edema
Exclusion Criteria
- Anticipated need for ocular surgery in the study eye during the study
- Laser photocoagulation in the study eye within 3 months
- Cataract surgery within 3 months
Data sourced from ClinicalTrials.gov (NCT02121262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.