Intravitreal bevacizumab (Avastin) in combination with verteporfin photodynamic therapy for choroidal neovascularization associated with age-related macular degeneration (IBeVe Study).
BACKGROUND
A novel alternative for combined treatment using verteporfin photodynamic therapy (PDT) has emerged as preliminary safety and efficacy data of the intravitreal use of the anti-angiogenic bevacizumab became available. In the current study we investigate the feasibility of intravitreal bevacizumab combined with verteporfin PDT for the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).


METHODS
A single-centre, prospective, open-label study of 11 patients with documented CNV progression after PDT treatment who underwent combined PDT and intravitreal injection of 1.5 mg of bevacizumab was undertaken. Standardized ophthalmic evaluation was performed at baseline and at weeks 1, 2, 12 and 24. Clinical evidence of complications and changes in logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and in fluorescein leakage from CNV were evaluated.


RESULTS
The mean (+/-SD) age of the 11 patients was 74 (+/-5) years. Seven eyes had been treated with one previous PDT session and four eyes had two previous PDT sessions. The mean baseline logMAR ETDRS BCVA was 1.031 (Snellen equivalent, 20/200(-2)). At follow-up weeks 1, 2, 12 and 24, the mean logMAR ETDRS BCVA (Snellen equivalent) was 0.944 (20/160(-2)), 0.924 (20/160(-1)), 0.882 (20/160(+1)), and 0.933 (20/160(-2)), respectively. The change in BCVA from baseline was significant at each study follow-up interval (P < or = 0.001); at 12 and 24 weeks, the mean change in BCVA from baseline was an improvement of 1.49 and of 0.98 ETDRS line, respectively. Fluorescein leakage from CNV was absent in all eyes at week 12. One additional treatment session was required in seven (63.6%) eyes at week 24 due to recurrent fluorescein leakage from CNV ("minimum" [<50% of the leaking area noted at baseline], n = 4; and "moderate" [>50% of the leaking area noted at baseline], n = 3). No progression of the neovascular lesion was observed at week 24. No safety issues were identified throughout the period of the study.


CONCLUSIONS
The overall changes in vision and fluorescein leakage from CNV throughout the study suggest that a possible synergistic effect may arise from the combination of intravitreal bevacizumab with verteporfin PDT for the treatment of neovascular AMD.
Costa
Rogério A
RA
U.D.A.T. Macular Imaging & Treatment Division, Hospital de Olhos de Araraquara, Rua Padre Duarte 989 apto 172, Araraquara, SP 14801-310, Brazil. roger.retina@globo.com
Jorge
Rodrigo
R
Calucci
Daniela
D
Melo
Luiz A S
LA
Cardillo
José A
JA
Scott
Ingrid U
IU
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007267:Injections; D008268:Macular Degeneration / Q000150:complications*; D008297:Male; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011166:Porphyrins / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D000077362:Verteporfin; D014792:Visual Acuity; D014822:Vitreous Body
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D017319:Photosensitizing Agents; D011166:Porphyrins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000077362:Verteporfin; D000068258:Bevacizumab