Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD
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|ClinicalTrials.gov Identifier: NCT00684853|
Recruitment Status : Unknown
Verified May 2008 by Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : May 28, 2008
Last Update Posted : May 28, 2008
|Condition or disease||Intervention/treatment||Phase|
|Macular Degeneration||Drug: bevacizumab Drug: vetaporfin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||May 2008|
|Active Comparator: 1||
1.25 mg of bevacizumab intravitreal
full fluence of vetaporfin
|Active Comparator: 2||
full fluence of vetaporfin
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684853
|Contact: Anderson G Teixeira, MDfirstname.lastname@example.org|
|Contact: Roberta Velletri, MDemail@example.com|
|Sao Paulo, SP, Brazil, 04023-062|
|Contact: Roberta Velletri, MD 11-5511-5085-2041 firstname.lastname@example.org|
|Contact: Tessa Mattos, MD 11-5511-5085-2041 email@example.com|