NCT00684853

Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD

Detailed description

Exudative AMD is the leader of blind in people more than 60 years. The best treatment for this disease today are monthly injections of anti-VEGF in the vitreous cavity which increase the chance to get endophthalmites. The participants of this study will be randomized in 1:1 ration to one of the two study groups: single therapy of bevacizumab (3 injections in 3 months) or association of bevacizumab (3 injections in 3 months) and full fluence of PDT (single at the baseline). All bevacizumab injection will contain 1.25g of the drug and will be administrate every month for 3 continuos months. After randomization, participants will return to the clinic approximately every four weeks for 4 months for study assessments and possible re-treatment (if is necessary). Participants will return to the clinic at week 20 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography and fundus photography.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	bevacizumab	1.25 mg of bevacizumab intravitreal
DRUG	vetaporfin	full fluence of vetaporfin

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-05-01
• First posted: 2008-05-28
• Last updated: 2008-05-28

Locations

1 site across 1 country: Brazil