Citation: Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. NEJM 2006; 355: 1419-1431.
- MARINA was a randomized, controlled trial comparing monthly ranibizumab 0.3mg or 0.5mg to verteporfin photodynamic therapy (PDT) for minimally classic or occult choroidal neovascularization (CNV) from age-related macular degeneration (AMD)
- At 24 months, ranibizumab 0.3mg or 0.5mg resulted in significantly better visual acuity outcomes, with significant visual acuity gains, than verteporfin photodynamic therapy (PDT), which resulted in significant visual acuity loss over 2 years
- Angiographic anatomical outcomes were significantly better with ranibizumab therapy
To study the efficacy of ranibizumab vs. sham for minimally classic or occult CNV in AMD
Randomized, multi-center, double-masked, phase 3, interventional clinical trial.
- AMD with minimally classic CNV or occult subfoveal CNV s with presumed recent progression (blood, recent “vision loss,” or ≥ 10% increase in lesion diameter)
Major Inclusion criteria:
RANDOMIZATION SCHEME AND INTERVENTIONS
Randomized 1:1:1 to
(a) monthly sham injections
(b) monthly intravitreal ranibizumab 0.3mg
(c) monthly intravitreal ranibizumab 0.5mg
Verteporfin PDT was allowed if CNV become predominantly classic.
Amendment later allowed for PDT for any subtype of CNVM if lesion > 4 DA and accompanied by loss of 20 letters of vision.
RESULTS (24 months)
- 716 subjects
- Study completion was 90% at 12 months and 80-90% at 24 months
Visual acuity end-points
- Loss of < 15 letters: 53% sham vs. 90-92% in both ranibizumab groups
- Gain of > 15 letter: 5% sham vs. 26% ranibizumab 0.3mg, 33% ranibizumab 0.5mg
- Mean VA change: sham -14.9 letters vs. ranibizumab 0.3mg +5.4 letters, ranibizumab 0.5mg +6.6 letters
- Arrest of lesion growth and leakage in ranibizumab groups
- Rates of any serious and non-serious ocular events, overall, similar between all groups
- Endophthalmitis was 1% per patient; 0.05% per injection
- No other cases of serious uveitis. Nonserious intraocular inflammation rate was 1% in both ranibizumab groups and mild (mostly trace-1+)
- Antiplatelet Trialists’ Collaboration criteria (ATCC) events were similar in all groups: 4% sham, 5% in both ranibizumab groups
- Ranibizumab 0.3mg and 0.5mg produced significantly better visual outcomes, compared to sham, in minimally classic or occult CNVM from AMD.