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

NCT ID: NCT01914159

Last Updated: 2019-08-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab

Group Type EXPERIMENTAL

Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)

Intervention Type DRUG

Monthly intravitreal injections

Interventions

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Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)

Monthly intravitreal injections

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Frank G. Holz

Director, Department of Ophthalmology, University of Bonn

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Bonn, Department of Ophthalmology

Bonn, , Germany

Site Status

University of München (LMU), Department of Ophthalmology

München, , Germany

Site Status

Universityof Münster, Department of Ophthalmology

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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N-037.0156

Identifier Type: -

Identifier Source: org_study_id

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