NCT00504400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

July 18, 2007

Last Update Submit

September 21, 2009

Conditions

Type 2 Idiopathic Macular Telangiectasia

Keywords

macular telangiectasiaparafoveal telangiectasisnonproliferativetherapyintravitreal injectionranibizumablucentis

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

    one year

Secondary Outcomes (5)

  • Reading ability

    one year

  • Scotomas measured by means of microperimetry

    one year

  • Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging

    one year

  • Changes in parafoveal leakage assessed by fluorescein angiography

    one year

  • Quality of life

    one year

Study Arms (1)

A

EXPERIMENTAL
Drug: Intravitreal injection ranibizumab

Interventions

Intravitreal injection ranibizumabDRUG

Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year

Also known as: Lucentis
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University of Bonn

Bonn, Germany

Location

Related Publications (2)

  • 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.

    PMID: 21334595DERIVED

  • 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.

    PMID: 20877651DERIVED

Related Links

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Frank Holz, MD

    University of Bonn, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

  • Hendrik PN Scholl, MD, MA

    University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 20, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

DE(1)