Effect of adjunctive diclofenac with verteporfin therapy to treat choroidal neovascularization due to age-related macular degeneration: phase II study.
BACKGROUND
To determine short-term effects of topical diclofenac administered in conjunction with verteporfin therapy for predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).


METHODS
Randomized, multicenter (14), prospective, placebo-controlled, double-masked clinical trial. Patients (n=61) were randomly assigned to treatment with diclofenac sodium ophthalmic solution 0.1% or placebo and followed for 12 weeks. Patients instilled diclofenac or placebo two drops four times daily, 2-4 days before verteporfin treatment until 2 weeks after treatment, then two drops twice daily for 10 weeks. This exploratory study was not powered to detect differences between treatment groups. Statistical analyses were conducted solely to aid interpretation of results.


RESULTS
In diclofenac-treated eyes, mean changes in visual acuity letter score from baseline in the diclofenac and placebo groups were +1.8 letters and -1.0 at week 1 (P=0.505 between groups). Mean visual acuity letter scores decreased in both groups at all subsequent visits, with a mean change at 12 weeks of -7.4 with diclofenac and -2.6 with placebo (P=0.213). Percentages of eyes with stable or improved vision (change <or=4 or increase >or=5 letters) were similar in the diclofenac and placebo groups at all study visits. No significant between-group differences in changes from baseline in lesion area, greatest linear dimension (GLD), fluorescein leakage, or retinal thickness were detected.


CONCLUSIONS
In patients with predominantly classic subfoveal CNV due to AMD, administration of topical diclofenac with verteporfin therapy was associated with similar vision outcomes to placebo plus verteporfin therapy.
Boyer
David S
DS
Beer
Paul M
PM
Joffe
Leonard
L
Koester
John M
JM
Marx
Jeffrey L
JL
Weisberger
Annemarie
A
Yoser
Seth L
SL
D000287:Administration, Topical; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; D004008:Diclofenac