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Completed

NCT Number: NCT01914159

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

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.

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Bonn, Department of Ophthalmology, Bonn, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)

Drug

Monthly intravitreal injections

Primary outcomes

  1. Best-corrected Visual Acuity

    Time frame: 12 months

    Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol

Secondary outcomes

  1. Retinal Morphology

    Time frame: 12 months

    Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness

  2. Vision-related Quality of Life

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Acronym: RIP

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2013
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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