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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00504400
First received: July 18, 2007
Last updated: September 21, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Type 2 Idiopathic Macular Telangiectasia
Drug: Intravitreal injection ranibizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reading ability [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Scotomas measured by means of microperimetry [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Changes in parafoveal leakage assessed by fluorescein angiography [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Intravitreal injection ranibizumab
Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
Other Name: Lucentis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504400

Locations
Germany
Department of Ophthalmology, University of Bonn
Bonn, Germany
Sponsors and Collaborators
University Hospital, Bonn
Novartis
Investigators
Principal Investigator: Frank Holz, MD University of Bonn, Department of Ophthalmology
Principal Investigator: Hendrik PN Scholl, MD, MA University of Bonn
  More Information

Additional Information:
No publications provided by University Hospital, Bonn

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Bonn
ClinicalTrials.gov Identifier: NCT00504400     History of Changes
Other Study ID Numbers: CRFB002ADE04, EudraCT number 2006-006233-40
Study First Received: July 18, 2007
Last Updated: September 21, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University Hospital, Bonn:
macular telangiectasia
parafoveal telangiectasis
nonproliferative
therapy
intravitreal injection
ranibizumab
lucentis

Additional relevant MeSH terms:
Telangiectasis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014