Macular Degeneration: Ward J

Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J, Anonymous00039. · Department of Ophthalmology, Retina Division, Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21205-2002, USA. · Arch Ophthalmol. · Pubmed #19139332 No free full text.

Abstract: OBJECTIVE: To compare patient-reported visual function in those with neovascular age-related macular degeneration treated with ranibizumab or verteporfin photodynamic therapy (PDT). DESIGN: Multicenter, double-masked, phase 3 trial (ANCHOR). Participants were randomized in a 1:1:1 ratio to receive 0.3 or 0.5 mg of intravitreal ranibizumab plus sham verteporfin or sham injections plus active verteporfin monthly. The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was administered at baseline and 1, 2, 3, 6, 9, 12, 18, and 24 months. MAIN OUTCOME MEASURE: Mean change from baseline in NEI VFQ-25 scores at 12 months. RESULTS: At 12 months, patients treated with ranibizumab (0.3 mg [n = 137] or 0.5 mg [n = 139]) had mean improvements in NEI VFQ-25 composite scores of 5.9 (95% confidence interval [CI], 3.6 to 8.3) and 8.1 (95% CI, 5.3 to 10.8) points, respectively; patients treated with PDT (n = 142) had a mean improvement of 2.2 points (95% CI, -0.3 to 4.7; vs 0.5 mg of ranibizumab, P < .001; vs 0.3 mg of ranibizumab, P = .003). At each dose through 24 months, patients treated with ranibizumab were more likely to improve in most subscales, including the prespecified subscales (near activities, distance activities, and vision-specific dependency). CONCLUSIONS: Patients treated with ranibizumab were more likely to report clinically meaningful improvements in visual function through 24 months compared with those treated with verteporfin PDT. Application to Clinical Practice Ranibizumab treatment in neovascular age-related macular degeneration can improve patient-reported visual function. Trial Registration clinicaltrials.gov Identifier: NCT00061594.

Chang TS, Bressler NM, Fine JT, Dolan CM, Ward J, Klesert TR, Anonymous00144. · Retina Institute of California, 800 S Fairmount Ave, Ste 312, Pasadena, CA 91105, USA. · Arch Ophthalmol. · Pubmed #17998507 links to  free full text

Abstract: OBJECTIVE: To examine the effects of ranibizumab on patient-reported visual function using the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) in patients with neovascular age-related macular degeneration (AMD). DESIGN: In MARINA, a randomized, double-masked clinical trial, 716 patients with AMD with recent disease progression and minimally classic or occult with no classic lesion component were randomized 1:1:1 to monthly intravitreal ranibizumab (0.3 or 0.5 mg) or sham injections. The NEI VFQ-25 was administered at 0, 1, 2, 3, 6, 9, 12, 18, and 24 months. Main Outcome Measure Mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. RESULTS: At 12 months, ranibizumab-treated patients (0.3 mg [n = 238] and 0.5 mg [n = 240]) had mean improvements in NEI VFQ-25 composite scores of +5.2 (95% confidence interval [CI], 3.5 to 6.9) and +5.6 (95% CI, 3.9 to 7.4), respectively; sham-injected patients (n = 238) had a mean decline of -2.8 (95% CI, -4.6 to -1.1; P < .001 vs each dose). Ranibizumab-treated patients were more likely to improve in near activities, distance activities, and vision-specific dependency through 24 months. CONCLUSIONS: In MARINA, ranibizumab-treated patients were more likely than sham-treated patients to report visual function improvements at 12 and 24 months. APPLICATION TO CLINICAL PRACTICE: Treatment of neovascular AMD with ranibizumab can improve patient-reported visual function in a meaningful way compared with sham treatments. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00056836.