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

Age Related Macular Degeneration Clinical Trial

— RIP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914159
• Other study ID #: N-037.0156
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2019
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
Monthly intravitreal injections

Locations

Country	Name	City	State
Germany	University of Bonn, Department of Ophthalmology	Bonn
Germany	University of München (LMU), Department of Ophthalmology	München
Germany	Universityof Münster, Department of Ophthalmology	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected Visual Acuity	Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol	12 months
Secondary	Retinal Morphology	Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness	12 months
Secondary	Vision-related Quality of Life	National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25); 0 to 100 scale, where 100 represents the best possible score and 0 represents the worst; Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8.	12 months