Intravitreal Bevacizumab associated with epiretinal brachitherapy as a treatment for Coroidal Neovascularization (CNV) secondary to exudative Age Related Macular Degeneration (AMD) - OFT-09-01

Conditions: exudative Age Related Macular Degeneration
MedDRA version: 12.1Level: LLTClassification code 10015902Term: Exudative senile macular degeneration of retina

Registration Number: EUCTR2009-016926-15-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients with CNV secondary to AMD, with an area ≤21.24 mm2 2. Patients must have completed 6 Bevacizumab intravitreal injections 3. Best corrected visual acuity within 69 and 24 ETDRS letters 4. subretinal haemorrhages smaller than 50% of the lesion area
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

1. Previous alternative treatment in the elected eye 2. Other ocular pathologies 3. Glaucomatous patients 4. CNV scarring bigger than 25% of the surface 5. Previous retina detachment 6. Haemovitreous 7. Previous vitrectomies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy of associating intravitreal Bevacizumab with epiretinal brachitherapy in reducing the number of intravitreal injections necessary to control the neovascular coroidal growth, and consequently to stabilize or improve Visual Acuity;Secondary Objective: Evaluate number of ETDRS letters gained or lost Variations of the dimensions of the lesion OCT-measured foveal thickness Evaluation of adverse reactions;Primary end point(s): reduce the number of intravitreal injections necessary to control the neovascular coroidal growth,

Secondary Outcome Measures