Phase 3
N=270
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Choroidal Neovascularization · Macular Edema · Glaucoma, Neovascular · Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01908816 ↗Enrolled (actual)
270
Serious AEs
26.3%
Results posted
Aug 2019
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 2; 21; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ranibizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
2; 21; 1; 0; 11; 15 | — |
| SECONDARY Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME) |
7.3; 4.5; 5.7; 5.2 | — |
| SECONDARY Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma |
12; 6; 8; 3; 2; 11 | — |
| SECONDARY Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy |
14; 3; 12; 1 | — |
| SECONDARY Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)" |
-54.4; -84.4; -56.4; -102.0 | — |
| SECONDARY Proportion of Patients With Angiographic Leakage |
3; 3; 1; 3; 3; 0 | — |
| SECONDARY Ranibizumab Injection |
2.5; 2.7; 1.7; 1.6; 3.8; 3.9 | — |
Summary
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.
Eligibility Criteria
Inclusion Criteria
- Active choroidal neovascularization (CNV)
- Active macular edema (ME)
- Rubeosis iridis/neovascular glaucoma.
- Proliferative diabetic retinopathy requiring vitrectomy.
Exclusion Criteria
- wet Age-related macular degeneration
- pathologic myopia
- pseudoxanthoma elasticum
- diabetic macular edema
- retinal vein occlusion
- < 18 years of age
- History of hypersensitivity to ranibizumab
- Use of any systemic anti-angiogenic drugs 3 months before inclusion
- Women of child-bearing potential and Pregnant or nursing (lactating) women.
- Active or suspected ocular infection
Data sourced from ClinicalTrials.gov (NCT01908816). 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.