Retina

ANCHOR Trial Summary 

Hypothesis/objective: 

Evaluated the efficacy of anti-vascular endothelial growth factor (VEGF) antibody versus verteporfin photodynamic therapy (PDT), in addition to efficacy of ranibizumab 0.3 mg versus ranibizumab 0.5 mg in the treatment of classic choroidal neovascularization (CNV) in age-related macular degeneration.    

Study design/protocol 
 
ANCHOR trial was a phase III, randomized, multicenter, double-masked, sham-controlled studies.  

The ANCHOR trial enrolled 423 patients with predominantly classic CNV lesions. Randomization was 1:1:1 with 143 patients assigned to PDT, 140 patients to treatment with ranibizumab 0.3 mg, and 140 patients to ranibizumab 0.5 mg. Patients were randomized 1:1:1 to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab (0.3 mg or 0.5 mg) injection. The need for PDT (active or sham) retreatment was evaluated every 3 months by fluorescein angiography (FA). 

Inclusion criteria:  

1. Age ≥50 years 

2. Subfoveal CNV secondary to AMD 

3. Study eye eligible for anticipated or expected treatment with PDT using verteporfin 

4. Predominately classic neovascularization ≥50% of the total lesion size 

5. Total lesion ≤ 5400 um in greatest linear dimension (~ DAs) 

6. Best corrected visual acuity 20/40-20/320 using Early treatment of Diabetic Retinopathy Study charts in the study eye 

ANCHOR specific inclusion criteria:  

Exclusion criteria:   

1. No prior PDT with verteporfin, external-beam radiation therapy or transpupillary thermotherapy in the study eye 

2. Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs 

3. Previous intravitreal drug delivery in study eye 

4. History of vitrectomy in study eye 

5. History of submacular surgery or other surgical intervention for AMD in study eye 

6. Subretinal hemorrhage in study eye that involves the fovea, if the hemorrhage size is 50% of the total lesion area or ≥1 DA in size 

7. CNV in either eye due to other causes  

8. Subfoveal fibrosis or atrophy in the study eye 

9. Active intraocular inflammation in the study eye 

10. Current vitreous hemorrhage in the study eye 

11. Uncontrolled glaucoma in study eye 

12. History of corneal transplant in study eye 

13. Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye 

ANCHOR:  

Primary endpoint/outcome 

1. Visual Acuity scores and Snellen equivalents through 12 months 

Secondary endpoint 

1. Changes in visual acuity (measured by number of letters read) from baseline through 12 months  

2. Changes from baseline in morphological lesion characteristics at 12 months 

Results: 

ANCHOR (for predominantly classic CNV) compared ranibizumab to verteporfin therapy, using mean visual acuity and the area occupied by choroidal neovascularization as points of comparison. The study found that ranibizumab therapy decreased the area of CNV, while verteporfin therapy led to a mean increase, establishing the superiority of ranibizumab over verteporfin for the treatment of classic neovascular AMD.[19] Table 2 summarizes the efficacy results from ANCHOR and MARINA. 

1. 94.3% in the 0.3 mg-ranibizumab-group and 96.4% in the 0.5 mg-group lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group 

2. Visual acuity in the 0.3-mg group (35.7%) and 0.5-mg group (40.3%) improved by 15 letters respectively, as compared with 5.6% of the verteporfin group 

3.  Mean visual acuity in the 0.3-mg group and 0.5-mg group increased by 8.5 and 11.3 letters respectively, as compared with a decrease of 9.5 letters in the verteporfin group  

4. Presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%) patient out of 140 patients treated with 0.5 mg of ranibizumab. 

Conclusions: 

1. Ranibizumab provided greater clinical benefit compared to verteporfin PDT in the treatment of classic choroidal neovascularization in patients with age-related macular degeneration. Rates of serious adverse events were low. Treatment improved visual acuity on average at 1 year.