Phase 3
Completed N=178
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
Choroidal Neovascularization (CNV)
Source: ClinicalTrials.gov NCT01840410 ↗
Enrolled (actual)
178
Serious AEs
7.3%
Results posted
Aug 2016
Primary outcomePrimary: Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 — 9.5; -0.4 letters — p=<0.001
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 |
9.5; -0.4 | <0.001 sig |
| SECONDARY Change From Baseline in BCVA in Study Eye up to Month 2 |
7.1; 0.1; 9.5; -0.4 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye |
-74.4; 3.3; -76.4; 1.9; -82.9; -59.1 | — |
| SECONDARY Change From Baseline in Central Subfield Volume (CSFV) in Study Eye |
-0.354; 0.012; -0.357; -0.006; -0.369; -0.269 | — |
| SECONDARY Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline |
70; 32; 46; 24; 97; 29 | — |
| SECONDARY Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline |
16; 6; 100; 50; 72; 11 | — |
| SECONDARY Number of Participants With Presence of Active Chorioretinal Leakage |
2; 1; 104; 49; 37; 4 | — |
| SECONDARY Average Change From Baseline in BCVA |
9.53; 4.68; 9.99; 6.59 | — |
| SECONDARY Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters |
37; 7; 50; 8; 83; 16 | — |
| SECONDARY Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss |
10; 24; 3; 12; 1; 5 | — |
| SECONDARY Number of Participants With Requirement for Rescue Treatment at Month 1 |
0; 1 | — |
| SECONDARY Number of Participants With Ranibizumab Treatments in Study Eye |
0; 0; 7; 12; 5; 0 | — |
| SECONDARY Number of Participants With Re-treatments |
25; 21; 0; 22; 10; 0 | — |
| SECONDARY Number of Primary Reasons for Decision to Treat by Investigator |
29; 9; 0; 522; 306; 1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
- BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
- Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
Key Exclusion Criteria
- Women of child-bearing potential;
- Active malignancies;
- History of stroke less than 6 months prior to screening;
- Uncontrolled systemic inflammation or infection;
- Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- CNV- conditions with a high likelihood of spontaneous resolution;
- History of intravitreal treatment with steroids;
- History of laser photocoagulation;
- History of intraocular treatment with any anti-angiogenic drugs.
Data sourced from ClinicalTrials.gov (NCT01840410). 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.