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

Sponsors and Collaborators:	University Hospital, Bonn Novartis
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00504400

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 II

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:	10
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Intravitreal injection ranibizumab Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over 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.

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

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 Hospital, Bonn

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Bonn ( University of Bonn )
Study ID Numbers:	CRFB002ADE04, EudraCT number 2006-006233-40
Study First Received:	July 18, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00504400 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by University Hospital, Bonn:

macular telangiectasia
parafoveal telangiectasis
nonproliferative
therapy

intravitreal injection
ranibizumab
lucentis

Study placed in the following topic categories:

Telangiectasis
Vascular Diseases

Additional relevant MeSH terms:

Telangiectasis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009