Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by University Hospital, Bonn.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Nicole Eter, University Hospital Muenster Identifier:
First received: September 11, 2009
Last updated: January 17, 2013
Last verified: January 2013
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: Endpoint Classification: Efficacy Study
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 University Hospital, Bonn:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mean change in best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in retinal thickness and height of pigment epithelial detachment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Central visual field and stability of fixation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Fluorescein leakage and changes in autofluorescence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Genders Eligible for Study:   Both
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
  Contacts and Locations
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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

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: January 17, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Retinal Detachment
Eye Diseases
Retinal Diseases processed this record on April 27, 2016