Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

Study Overview
=================
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.

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

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: vetaporfin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: bevacizumab<br>* 1.25 mg of bevacizumab intravitreal<br>Drug: vetaporfin<br>* full fluence of vetaporfin<br>|
| Active Comparator: 2<br> | Drug: vetaporfin<br>* full fluence of vetaporfin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months |  | 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall probability of re-injection |  | 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 |  | 4 | 
| Mean change in area of leakage, CNV and lesion by the FA and ICG |  | 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, PDT, Avastin, Bevacizumab, Full fluence, exudative, CNV, Drusen, ARMD, Vetaporfin, efficacy, treatment