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Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976222
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : September 29, 2017
Information provided by (Responsible Party):
Nicole Eter, University Hospital Muenster

Brief Summary:
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 or disease Intervention/treatment Phase
Pigment Epithelial Detachment Drug: intravitreal injection with ranibizumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration
Study Start Date : December 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Arm Intervention/treatment
1 Arm Ranibizumab Drug: intravitreal injection with ranibizumab
0.5 mg in 0.05 ml, monthly, 12 months
Other Name: Lucentis

Primary Outcome Measures :
  1. 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 :
  1. Safety [ Time Frame: 12 months ]
  2. Mean change in best corrected visual acuity [ Time Frame: 12 months ]
  3. Change in retinal thickness and height of pigment epithelial detachment [ Time Frame: 12 months ]
  4. Central visual field and stability of fixation [ Time Frame: 12 months ]
  5. Fluorescein leakage and changes in autofluorescence [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00976222

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University Hospital Muenchen
Muenchen, Germany, 80336
University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
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Principal Investigator: Nicole Eter, MD Dept. of Ophthalmology, University of Muenster Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nicole Eter, Director of Ophthalmology Department, University Hospital Muenster Identifier: NCT00976222    
Other Study ID Numbers: AMD-PED 08
Eudra-CT: 2008-004675-22
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents