Phase 2
Completed N=24
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
Source: ClinicalTrials.gov NCT01914159 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Best-corrected Visual Acuity — 52.9 ETDRS letters
Summary
The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best-corrected Visual Acuity |
52.9 | — |
| SECONDARY Retinal Morphology |
436 | — |
| SECONDARY Vision-related Quality of Life |
74.3 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
- Written informed consent
Exclusion Criteria
- Time of diagnosis more than 6 months before study recruitment
- Ocular surgery of the study eye within 1 month before study recruitment
- Extensive subretinal fibrosis or retinal atrophy of the study eye
- Significant opacification of optical media of the study eye
- Uncontrolled glaucoma of the study eye
- Active ocular inflammation of the study eye
- Best-corrected visual acuity of the contralateral eye below 20/200
- Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs
Data sourced from ClinicalTrials.gov (NCT01914159). 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.