Clinical trial NCT00684853: Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD
Official title: Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: AMD
PDT
Avastin
Bevacizumab
Full fluence
exudative
CNV
Drusen
ARMD
Vetaporfin
efficacy
treatment
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months
timeFrame: 4
Secondary outcomes:
measure: The overall probability of re-injection
timeFrame: 4
measure: 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
timeFrame: 4
measure: Mean change in area of leakage, CNV and lesion by the FA and ICG
timeFrame: 4
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: UNIFESP
state: SP
Study officials:
References:
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citation: Ladas ID, Kotsolis AI, Papakostas TD, Rouvas AA, Karagiannis DA, Vergados I. Intravitreal bevacizumab combined with photodynamic therapy for the treatment of occult choroidal neovascularization associated with serous pigment epithelium detachment in age-related macular degeneration. Retina. 2007 Sep;27(7):891-6. doi: 10.1097/IAE.0b013e3180ca9ad9.
citation: Ladewig MS, Karl SE, Hamelmann V, Helb HM, Scholl HP, Holz FG, Eter N. Combined intravitreal bevacizumab and photodynamic therapy for neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):17-25. doi: 10.1007/s00417-007-0654-x. Epub 2007 Aug 15.
citation: Hahn R, Sacu S, Michels S, Varga A, Weigert G, Geitzenauer W, Vecsei-Marlovits P, Schmidt-Erfurth U. [Intravitreal bevacizumab versus verteporfin and intravitreal triamcinolone acetonide in patients with neovascular age-related macula degeneration]. Ophthalmologe. 2007 Jul;104(7):588-93. doi: 10.1007/s00347-007-1547-4. German.
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citation: Costa RA, Jorge R, Calucci D, Melo LA Jr, Cardillo JA, Scott IU. Intravitreal bevacizumab (Avastin) in combination with verteporfin photodynamic therapy for choroidal neovascularization associated with age-related macular degeneration (IBeVe Study). Graefes Arch Clin Exp Ophthalmol. 2007 Sep;245(9):1273-80. doi: 10.1007/s00417-007-0557-x. Epub 2007 Feb 28.
citation: Augustin AJ, Puls S, Offermann I. Triple therapy for choroidal neovascularization due to age-related macular degeneration: verteporfin PDT, bevacizumab, and dexamethasone. Retina. 2007 Feb;27(2):133-40. doi: 10.1097/IAE.0b013e3180323de7.