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

Primary Purpose

Type 2 Idiopathic Macular Telangiectasia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Intravitreal injection ranibizumab
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Idiopathic Macular Telangiectasia focused on measuring macular telangiectasia, parafoveal telangiectasis, nonproliferative, therapy, intravitreal injection, ranibizumab, lucentis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, University of Bonn

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Best corrected visual acuity

Secondary Outcome Measures

Reading ability
Scotomas measured by means of microperimetry
Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging
Changes in parafoveal leakage assessed by fluorescein angiography
Quality of life

Full Information

First Posted
July 18, 2007
Last Updated
September 21, 2009
Sponsor
University Hospital, Bonn
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00504400
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Idiopathic Macular Telangiectasia
Keywords
macular telangiectasia, parafoveal telangiectasis, nonproliferative, therapy, intravitreal injection, ranibizumab, lucentis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
one year
Secondary Outcome Measure Information:
Title
Reading ability
Time Frame
one year
Title
Scotomas measured by means of microperimetry
Time Frame
one year
Title
Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging
Time Frame
one year
Title
Changes in parafoveal leakage assessed by fluorescein angiography
Time Frame
one year
Title
Quality of life
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Holz, MD
Organizational Affiliation
University of Bonn, Department of Ophthalmology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hendrik PN Scholl, MD, MA
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, University of Bonn
City
Bonn
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21334595
Citation
Charbel Issa P, Finger RP, Kruse K, Baumuller S, Scholl HP, Holz FG. Monthly ranibizumab for nonproliferative macular telangiectasia type 2: a 12-month prospective study. Am J Ophthalmol. 2011 May;151(5):876-886.e1. doi: 10.1016/j.ajo.2010.11.019. Epub 2011 Feb 19. Erratum In: Am J Ophthalmol. 2011 Jul;152(1):151.
Results Reference
derived
PubMed Identifier
20877651
Citation
Charbel Issa P, Troeger E, Finger R, Holz FG, Wilke R, Scholl HP. Structure-function correlation of the human central retina. PLoS One. 2010 Sep 22;5(9):e12864. doi: 10.1371/journal.pone.0012864.
Results Reference
derived
Links:
URL
http://www.augenklinik.uni-bonn.de
Description
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Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)

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