Phase 4
Completed N=71
A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
Source: ClinicalTrials.gov NCT01903720 ↗Enrolled (actual)
71
Serious AEs
2.8%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6 — 51.90; 18.60 letters
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6 |
51.90; 18.60 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Month 6 |
505.13; -246.82 | — |
| SECONDARY Change From Baseline in BCVA at Month 12 |
51.90; 15.27 | — |
| SECONDARY Change From Baseline in CRT at Month 12 |
505.13; -196.90 | — |
| SECONDARY Change From Baseline in BCVA at Each Visit |
51.90; 12.80; 16.08; 18.84; 17.59; 14.37 | — |
| SECONDARY Change From Baseline in CRT at Each Visit |
505.13; -173.67; -229.48; -255.55; -188.17; -100.76 | — |
| SECONDARY Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA |
64.52; 1.61; 55.93; 5.08 | — |
| SECONDARY Percentage of Participants Receiving a Second Injection |
18.31 | — |
| SECONDARY Percentage of Participants Receiving a Third Injection |
49.30 | — |
| SECONDARY Time to Second Injection |
20.78 | — |
| SECONDARY Time to Third Injection |
19.20 | — |
| SECONDARY Percentage of Participants Who Received Laser Treatments |
0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of macular edema
- Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye
Exclusion Criteria
- Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
- Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
- Any active ocular infection in either eye
Data sourced from ClinicalTrials.gov (NCT01903720). 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.