Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD
- Registration Number
- NCT00684853
- Lead Sponsor
- Federal University of São Paulo
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- more or iqual 50 years old
- male or female
- Choroidal neovascularization sub or just foveal the fovea secondary to AMD (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
- Greatest linear dimension (GLD) of entire lesion < 5400 µm (no reading center confirmation required)
- ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
- Total area of lesion must < 9 MPS DA
- pre-treatment
- ETDRS best corrected visual acuity better than 34 letters
- macular surgery history
- laser photocoagulation in the study eye within 30 dais
- eye surgery within 30 days
- history of no-treat glaucoma
- acuite uveits
- history of endophthalmites
- vitreous hemorrhage
- geographic atrophy or fibrosis corresponding > 50% of the lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 vetaporfin - 2 vetaporfin - 1 bevacizumab -
- Primary Outcome Measures
Name Time Method The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months 4
- Secondary Outcome Measures
Name Time Method Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 200 microns) of ³50% and of at least 50 microns from baseline 4 The overall probability of re-injection 4 Mean change in area of leakage, CNV and lesion by the FA and ICG 4
Trial Locations
- Locations (1)
UNIFESP
🇧🇷Sao Paulo, SP, Brazil