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Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

This study has been completed.
Information provided by (Responsible Party):
Nicole Eter, University Hospital Muenster Identifier:
First received: September 11, 2009
Last updated: June 1, 2016
Last verified: June 2016
The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).

Condition Intervention Phase
Pigment Epithelial Detachment Drug: intravitreal injection with ranibizumab Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration

Resource links provided by NLM:

Further study details as provided by Nicole Eter, University Hospital Muenster:

Primary Outcome Measures:
  • To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months ]
  • Mean change in best corrected visual acuity [ Time Frame: 12 months ]
  • Change in retinal thickness and height of pigment epithelial detachment [ Time Frame: 12 months ]
  • Central visual field and stability of fixation [ Time Frame: 12 months ]
  • Fluorescein leakage and changes in autofluorescence [ Time Frame: 12 months ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Arm Ranibizumab Drug: intravitreal injection with ranibizumab
0.5 mg in 0.05 ml, monthly, 12 months
Other Name: Lucentis

Detailed Description:
Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a special entity in AMD. As yet, no standard treatment has been established for this disease.The stimuli that induce PED are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (VEGF) also play a role in the pathogenesis. Ranibizumab is an anti-VEGF antibody fragment that blocks VEGF activity in patients with neovascular AMD.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (OCT)
  • patients who have a best-corrected visual acuity (BCVA) score between 73 and 24 ETDRS letters
  • patients with pigment epithelial detachment (PED) ≥ 200 µm as determined by OCT
  • male or female patients 50 years of age or greater
  • patients willing and able to comply with all study procedures

Exclusion Criteria:

  • patients with best-corrected visual acuity (BCVA) < 24 or >73 letters in the study eye
  • patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation
  • history of uncontrolled glaucoma in the study eye
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Please refer to this study by its identifier: NCT00976222

University Hospital Muenchen
Muenchen, Germany, 80336
University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital, Bonn
Principal Investigator: Nicole Eter, MD Dept. of Ophthalmology, University of Muenster Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nicole Eter, Director of Ophthalmology Department, University Hospital Muenster Identifier: NCT00976222     History of Changes
Other Study ID Numbers: AMD-PED 08
Eudra-CT: 2008-004675-22
Study First Received: September 11, 2009
Last Updated: June 1, 2016

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on August 16, 2017