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

U

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)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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