Phase 4
Completed N=40
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
Source: ClinicalTrials.gov NCT01309451 ↗Enrolled (actual)
40
Serious AEs
33.3%
Results posted
Oct 2014
Primary outcomePrimary: Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline — 4.9; 5.4 letters
Summary
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline |
4.9; 5.4 | — |
| PRIMARY OCT CST |
30; 45 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female age 18 years or older
- Type 1 or type 2 diabetes
- BCVA score of >24 and 250microns
Exclusion Criteria
- Anti-VEGF intravitreal treatment in last 4 weeks
- Intravitreal steroid treatment in the last 8 weeks
- PRP or Focal laser in last 4 months
- Active iris neovascularization
Data sourced from ClinicalTrials.gov (NCT01309451). 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.