Treat-and-Extend With Ranibizumab: Two-Year Results
JAMA Ophthalmology, March 2020
In a randomized clinical trial, Kertes et al. compared the efficacy of monthly intravitreal injections of ranibizumab to that seen with a treat-and-extend (T&E) approach for choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration. They found that, through 24 months, the T&E regimen resulted in clinically meaningful improvement in best-corrected visual acuity (BCVA) that was not worse than that achieved with monthly treatment.
For this trial, the researchers enrolled 580 treatment-naive patients with CNV. Patients were randomized 1:1 to receive intravitreal ranibizumab 0.5 mg in either a T&E or a monthly dosing regimen. The main outcome measure was mean change in BCVA from baseline to month 24. By the two-year mark, 466 (80.3%) of the 580 patients had completed the study, as 49 patients (19.5%) withdrew from the T&E arm and 65 (21.8%) withdrew from the monthly treatment arm.
At month 24, results were as follows:
- For the primary outcome, the mean (standard deviation) change in VA was not worse in the T&E treatment group (6.8 [14.1] letters) compared with the monthly treatment group (6.0 [12.6] letters; difference, 0.9; 95% confidence interval [CI], –1.6-3.3; p = 0.21).
- At month 24, a lower mean number of injections was reported for T&E treatment (17.6) than with the monthly dosing regimen (23.5; difference, 5.9; 95% CI, 5.4-6.5; p < 0.001).
- In the T&E arm, 73.7% (95% CI, 67.6%-79.3%) of the patients were able to extend their treatment interval to eight or more weeks during the 24 months of treatment, and 43.1% (95% CI, 36.6%-49.8%) of the patients reached the 12-week maximum extension interval.
- In the T&E group, 42.9% gained 10 or more letters from baseline, while 25.5% gained 15 or more letters. In contrast, 36.4% in the monthly treatment group gained 10 or more letters, while 23.1% gained 10 or more letters.
- With regard to letters lost, 9.5% in the T&E group lost 10 or more letters, while 6.5% lost 15 or more letters. The rates were similar in the monthly treatment group, as 9.8% lost 10 or more letters and 5.8% lost 15 or more letters.
The study has been extended to 36 months, with all participants receiving ranibizumab on a T&E basis.
The original article can be found here.