EUCTR2006-006233-40-DE
Active, not recruiting
Phase 1
Ranibizumab in idiopathic macular telangiectasia, type2 A prospective interventional non-randomized study comparing the efficacy and safety of intravitreal ranibizumab (dosing regimen 0.5mg every month over a period of one year) in type 2 idiopathic macular telangiectasia[Intravitreales Ranibizumab zur Therapie von idiopathischen makulären Teleangiektasien, Typ 2]
Department of Ophthalmology, Bonn University0 sites10 target enrollmentMarch 6, 2007
ConditionsTypical findings in Type 2 idiopathic macular telangiectasia (type2-IMT)are parafoveal ectatic capillaries, The disease is characterized by a slow decrease in visual acuity, reading difficulties and/or metamorphopsia starting in the fifth to seventh decade. Both atrophy and secondary choroidal neovascularisation may occur with disease progression. So far there has been no therapy with proven benefit for type2-IMT.MedDRA version: 9.1Level: LLTClassification code 10064761Term: Parafoveal telangiectasia
DrugsLucentis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Typical findings in Type 2 idiopathic macular telangiectasia (type2-IMT)are parafoveal ectatic capillaries, The disease is characterized by a slow decrease in visual acuity, reading difficulties and/or metamorphopsia starting in the fifth to seventh decade. Both atrophy and secondary choroidal neovascularisation may occur with disease progression. So far there has been no therapy with proven benefit for type2-IMT.
- Sponsor
- Department of Ophthalmology, Bonn University
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years
- •Written Informed Consent has been obtained.
- •Best corrected visual acuity in the study eye: 20/200 \- 20/32\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Patients with other retinal vascular diseases. such as Diabetic Retinopathy or retinal vascular occlusion
- •Previous intravitreal Injection of antiangiogenetic drugs into the study eye within the last 6 months.
- •Any surgery in the study eye within the last 3 months prior to inclusion into the study.
- •History of an uncontrolled glaucoma in the study eye
- •active inflammation in the study eye or the acular adnexa
- •Subfoveal fibrosis in the study eye
- •Inability to comply with the study protocol
- •Major general surgery one month prior to inclusion into the study
- •Known allergy to humanized antibodies
- •Pregnancy or insufficient contraception
Outcomes
Primary Outcomes
Not specified
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