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Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)

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ClinicalTrials.gov Identifier: NCT00504400
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : September 22, 2009
Sponsor:
Collaborator:
Novartis
Information provided by:
University Hospital, Bonn

Tracking Information
First Submitted Date  ICMJE July 18, 2007
First Posted Date  ICMJE July 20, 2007
Last Update Posted Date September 22, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
Best corrected visual acuity [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
  • Reading ability [ Time Frame: one year ]
  • Scotomas measured by means of microperimetry [ Time Frame: one year ]
  • Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging [ Time Frame: one year ]
  • Changes in parafoveal leakage assessed by fluorescein angiography [ Time Frame: one year ]
  • Quality of life [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
  • Reading ability [ Time Frame: one year ]
  • Scotomas measured by means of microperimetry [ Time Frame: one year ]
  • Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging [ Time Frame: one year ]
  • Changes in parafoeal leakage assessed by fluorescein angiography [ Time Frame: one year ]
  • Quality of life [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)
Official Title  ICMJE Ranibizumab in Idiopathic Macular Telangiectasia, Type 2. A Prospective Interventional Non-randomized Study Comparing the Efficacy and Safety of Intravitreal Ranibizumab in Type 2 Idiopathic Macular Telangiectasia.
Brief Summary The purpose of this study is to investigate if a new drug called ranibizumab is effective to treat a rare bilateral disease of the macula: type 2 idiopathic macular telangiectasia (type 2 IMT). 10 patients will receive monthly injections of the drug into one eye over a period of one year.
Detailed Description

Type 2 idiopathic macular telangiectasia (type 2 IMT) is a retinal disease of unknown etiology that commonly presents with a slow decrease in visual acuity, reading difficulties and metamorphopsia in the fifth to seventh decade. Diagnosis is based on fluorescein angiography which typically reveals parafoveal leakage in the late phase and may show telangiectatic capillaries in the early phase. In a subset of patients, a proliferative stage with secondary neovascularizations may develop late in the disease course. In the past, there has been no effective treatment for the disease stages without neovascularization.

Recent studies in a limited number of patients with nonproliferative disease have shown promising results after intravitreal injection of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF). Bevacizumab resulted in a decrease of parafoveal leakage in fluorescein angiography and a decrease in retinal thickness. An increase in visual acuity was reported in a subset of patients.

The RAMA-Trial is initiated in order to investigate the effect of a ranibizumab. The safety and tolerability of this VEGF-antagonist has been extensively studied in large cohorts of patients suffering from age-related macular degeneration.

Patients with type 2 IMT will receive monthly injections over a period of one year. The above mentioned outcome measures will be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Idiopathic Macular Telangiectasia
Intervention  ICMJE Drug: Intravitreal injection ranibizumab
Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
Other Name: Lucentis
Study Arms  ICMJE Experimental: A
Intervention: Drug: Intravitreal injection ranibizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2007)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of type 2 idiopathic macular telangiectasia
  • minimum of 18 years
  • patient must be able to follow protocol
  • written informed consent
  • best corrected visual acuity between 20/200 - 20/32 in the treated eye

Exclusion Criteria:

  • patients who do not fulfill the inclusion criteria
  • patients with other retinal vascular disease such as diabetic retinopathy or venous occlusive diseases
  • ocular surgery 3 months before study enrollment
  • history of uncontrolled glaucoma
  • active intraocular inflammation or inflammation of the ocular adnexa
  • subfoveal fibrosis in the study eye
  • inability to follow study protocol
  • major surgery one month before study enrollment
  • history of severe cardiovascular disease or history of stroke 6 months before study enrollment
  • allergies against substances or components of the study medication
  • low anticipated compliance
  • patients who participate(d) in clinical trials simultaneously or within the last 60 days
  • pregnancy, lactation, women that may become pregnant and don't use safe contraception
  • chronic alcohol- or drug abuse within the last year
  • lacking legal competence or language ability
  • neurologic diseases such as multiple sclerosis
  • need of concomitant medication that is not allowed in combination with ranibizumab
  • previous intravitreal therapy with anti-angiogenic substances in the study eye within the last 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00504400
Other Study ID Numbers  ICMJE CRFB002ADE04
EudraCT number 2006-006233-40
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Bonn
Study Sponsor  ICMJE University Hospital, Bonn
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Frank Holz, MD University of Bonn, Department of Ophthalmology
Principal Investigator: Hendrik PN Scholl, MD, MA University of Bonn
PRS Account University Hospital, Bonn
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP