The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD
Full Title of Study: “Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 2008
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.
- Drug: bevacizumab
- 1.25 mg of bevacizumab intravitreal
- Drug: vetaporfin
- full fluence of vetaporfin
Arms, Groups and Cohorts
- Active Comparator: 1
- Active Comparator: 2
Clinical Trial Outcome Measures
- The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months
- Time Frame: 4
- The overall probability of re-injection
- Time Frame: 4
- 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
- Time Frame: 4
- Mean change in area of leakage, CNV and lesion by the FA and ICG
- Time Frame: 4
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Federal University of São Paulo
- Provider of Information About this Clinical Study
- Anderson Teixeira, MD, UNIFESP
- Overall Contact(s)
- Anderson G Teixeira, MD, 323-442-6672, firstname.lastname@example.org
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