Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

Federal University of São Paulo

Status and phase: Unknown; Phase 2

Conditions: Macular Degeneration

Treatments: Drug: bevacizumab; Drug: vetaporfin

Study type: Interventional

Funder types: Other

Identifiers

NCT00684853

Pep1

Details and patient eligibility

About

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 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: vetaporfin

Drug: bevacizumab

2

Active Comparator group

Treatment:

Drug: vetaporfin