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

University Hospital Bonn (UKB)

Status and phase: Completed; Phase 2

Conditions: Age Related Macular Degeneration

Treatments: Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT01914159

N-037.0156

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Ranibizumab

Experimental group

Treatment:

Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)