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

Brief Title

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

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.

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Best corrected visual acuity

Secondary Outcome

 Reading ability

Condition

Type 2 Idiopathic Macular Telangiectasia

Intervention

Intravitreal injection ranibizumab

Study Arms / Comparison Groups

 A
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

August 2007

Completion Date

September 2009

Primary Completion Date

June 2009

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Frank Holz, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00504400

Organization ID

CRFB002ADE04

Secondary IDs

EudraCT number 2006-006233-40


Study Sponsor

University Hospital, Bonn

Collaborators

 Novartis

Study Sponsor

Frank Holz, MD, Principal Investigator, University of Bonn, Department of Ophthalmology


Verification Date

September 2009