Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: phase II study results.
OBJECTIVE
There is evidence to suggest that anti-vascular endothelial growth factor (anti-VEGF) therapy may be useful in treating ocular neovascularization. A phase IA single intravitreal injection study of anti-VEGF therapy for patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) revealed a good safety profile. We performed a phase II multiple injection study of anti-VEGF therapy with and without photodynamic therapy for patients with subfoveal CNV secondary to AMD to determine the safety profile of multiple injection therapy.


METHODS
A phase II multiple-dose safety study.


METHODS
Twenty-one patients were treated with intravitreal injection with and without photodynamic therapy.


METHODS
Clinical evidence of toxicity and complications.


RESULTS
No drug-related serious adverse events were revealed. Ophthalmic evaluation revealed that 87.5% of patients who received the anti-VEGF aptamer alone showed stabilized or improved vision 3 months after treatment and that 25% of eyes demonstrated a 3 line or greater improvement in vision on the Early Treatment of Diabetic Retinopathy Study chart during this period. A 60% 3 line gain at 3 months was noted in patients who received both the anti-VEGF aptamer and photodynamic therapy.


CONCLUSIONS
Anti-VEGF therapy is a promising treatment for various forms of ocular neovascularization, including AMD. Multiple intravitreal injections of the anti-VEGF aptamer were well tolerated in this phase II study. Further clinical trials are necessary to demonstrate the efficacy and long-term safety of anti-VEGF therapy for AMD.
D000368:Aged; D000369:Aged, 80 and over; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D003131:Combined Modality Therapy; D016228:Endothelial Growth Factors / Q000037:antagonists & inhibitors*; D005260:Female; D005584:Fovea Centralis; D006801:Humans; D007267:Injections; D036341:Intercellular Signaling Peptides and Proteins; D008222:Lymphokines / Q000037:antagonists & inhibitors*; D008268:Macular Degeneration / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009841:Oligonucleotides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use; D011166:Porphyrins / Q000627:therapeutic use; D012449:Safety; D042461:Vascular Endothelial Growth Factor A; D042442:Vascular Endothelial Growth Factors; D000077362:Verteporfin; D014792:Visual Acuity; D014822:Vitreous Body
D016228:Endothelial Growth Factors; D036341:Intercellular Signaling Peptides and Proteins; D008222:Lymphokines; D009841:Oligonucleotides; D017319:Photosensitizing Agents; D011166:Porphyrins; D042461:Vascular Endothelial Growth Factor A; D042442:Vascular Endothelial Growth Factors; D000077362:Verteporfin; C430291:NX1838