Self–Reported Vision–Specific Quality of Life at 1 Year in Patients With Neovascular Age–Related Macular Degeneration in 2 Phase Iii Randomized Clinical Trials of Ranibizumab (LucentisTm)

Abstract

 

Objectives:

 

To examine effects of ranibizumab (Lucentis^TM) on patient–reported vision–specific quality of life (QoL) using the National Eye Institute Visual Function Questionnaire–25 (NEI VFQ–25) through 12 months in 2 Phase III randomized trials_MARINA and ANCHOR.

 

Methods:

 

The NEI–VFQ 25 was administered to subjects with subfoveal choroidal neovascularization due to AMD with minimally classic or occult with no classic types in MARINA and the predominantly classic type in ANCHOR at baseline and months 1, 2, 3, 6, 9, and 12. In MARINA, subjects were randomized 1:1:1 to sham, 0.3 mg, and 0.5 mg ranibizumab. In ANCHOR, subjects were randomized 1:1:1 to verteporfin (Visudyne^TM) photodynamic therapy, 0.3 mg, and 0.5 mg ranibizumab. Results were compared between treatment groups at 1 year.

 

Results:

 

716 subjects (238 sham, 238 0.3 mg, 240 0.5 mg) at baseline and 663 subjects (212 sham, 225 0.3 mg, 226 0.5 mg) at 1 year in MARINA and 418 subjects (142 verteporfin, 137 0.3 mg, 139 0.5 mg) at baseline and 379 subjects (126 verteporfin, 125 0.3 mg, 128 0.5 mg) at 1 year in ANCHOR were studied. Results for MARINA are shown below. Mean changes from baseline score (last observation carried forward method) *ranibizumab pooled dose groups vs sham injection group ⁺increases in dependency scale = reduced dependency Results from ANCHOR hadn’t been analyzed at the time of abstract submission, but will be presented. 

 

Conclusions:

 

The MARINA trial is the first to demonstrate improvements in vision–specific QoL following pharmacologic intervention in AMD. On average in MARINA, ranibizumab–treated subjects reported improvements in their ability to perform activities related to near and distance vision while sham subjects reported decreases in their ability to perform these activities. Ranibizumab–treated subjects reported on average decreased levels of vision–related dependency compared to sham subjects.

 

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • quality of life