Phase 2 N=24 Treatment

Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study

Age Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT01914159 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Best-corrected Visual Acuity — 52.9 ETDRS letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany) (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University Hospital, Bonn
Primary completion: Mar 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

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.