Abstract
Abstract: :
Purpose: To determine the effect of topical diclofenac sodium ophthalmic solution on visual acuity in patients treated with verteporfin therapy for predominantly classic subfoveal CNV secondary to AMD. Methods: Patients were eligible for the study if they were at least 50 years old and had predominantly classic CNV (classic CNV occupying ≥50% of the lesion), a lesion with a greatest linear dimension of ≤5400 µm, and a best–corrected visual acuity score of 20/200 or better. In addition, eligible patients had not previously received verteporfin therapy. Patients were randomly assigned (1:1) to treatment with diclofenac (n=30) or placebo (n=31) for 12 weeks. Diclofenac or placebo was administered as two drops four times daily from 2–4 days before treatment until 2 weeks after verteporfin therapy, then as two drops twice daily for 10 additional weeks. Best–corrected visual acuity was recorded at baseline and 1, 4, 8, and 12 weeks after verteporfin therapy. Angiographic outcomes were measured at baseline and each visit after 1 week. Results: Sixty–one patients from 14 centers were enrolled in the study. Baseline characteristics were balanced with a mean visual acuity letter score of 49.0 (approximate Snellen equivalent 20/100–1). Mean visual acuity for all evaluable patients increased by 1.8 letters from baseline at week 1 in the diclofenac–treated group, then decreased at each subsequent visit to a total loss of –7.4 letters from baseline at month 3. In the placebo group, mean visual acuity score decreased from baseline at each visit; –5.3 letters at month 2, and –2.6 letters at month 3 for a total loss of 7.9 letters from baseline at month 3. Differences between treatment groups in the mean change from baseline were not statistically significant at any visit (P=0.213). The incidence of transient visual disturbances observed in this study was low (2 [7%] diclofenac, 1 [3%] placebo). Conclusions: There was no difference in visual acuity outcomes between verteporfin patients who received applications of topical diclofenac and those who received placebo drops. However, further evaluation in larger studies with different dosing regimens or methods of drug delivery would be needed to evaluate the therapeutic benefit and long–term outcomes of combination regimens.
Keywords: age–related macular degeneration • choroid: neovascularization • photodynamic therapy