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Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

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ClinicalTrials.gov Identifier: NCT00976222
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Primary Completion Date : December 2014
Study Completion Date : December 2015


Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00976222


Locations
Germany
University Hospital Muenchen
Muenchen, Germany, 80336
University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Novartis
Investigators
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
ClinicalTrials.gov Identifier: NCT00976222     History of Changes
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:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents