Phase 3
Completed N=243
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)
Source: ClinicalTrials.gov NCT01396083 ↗Enrolled (actual)
243
Serious AEs
10.7%
Results posted
Feb 2015
Primary outcomePrimary: Mean Average BCVA Change From Month 1 Through Month 6 to Baseline — 14.6; 4.8 Letters
Summary
This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Average BCVA Change From Month 1 Through Month 6 to Baseline |
14.6; 4.8 | — |
| SECONDARY Mean BCVA Change at Month 6 |
14.78; -3.17 | — |
| SECONDARY Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters |
73; 22; 1; 31; 89; 38 | — |
| SECONDARY Time to Achieve a Significant Improvement ≥ 15 Letters |
62; 98 | — |
| SECONDARY Change Over Time in BCVA |
9.77; 9.54; 12.25; 11.04; 14.04; 4.99 | — |
| SECONDARY Change Over Time of the Central Retinal Thickness (CRT) |
-376.7; -168.7 | — |
| SECONDARY Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires |
6.0; 2.0 | — |
| SECONDARY Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires |
-0.7; 0.4; 2.4; 0.4 | — |
| SECONDARY Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires |
0.1; 2.0 | — |
| SECONDARY Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline |
94; 105 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with visual impairment due to macular edema following CRVO
- Diagnosis of CRVO at maximum 6 months prior to Screening
- BCVA using ETDRS charts of 20/40 to 20/400 in the study eye
Exclusion Criteria
- Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
- Central retinal thickness (CRT) 10 letters on BCVA between Screening and Baseline
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01396083). 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.