EFFICACY AND SAFETY OF RANIBIZUMAB FOR THE TREATMENT OF CHOROIDAL NEOVASCULARIZATION DUE TO UNCOMMON CAUSE: Twelve-Month Results of the MINERVA Study

Abstract

Purpose: To evaluate the efficacy and safety of ranibizumab 0.5 mg in adult patients with choroidal neovascularization because of an uncommon cause enrolled in the 12-month MINERVA study.

Methods: In this Phase III, double-masked study, adult (≥18 years) patients (N = 178) were randomized 2:1 to receive either ranibizumab (n = 119) or sham (n = 59) at baseline and, if needed, at Month 1 and open-label individualized ranibizumab from Month 2. Best-corrected visual acuity change from baseline to Month 2 (primary endpoint) and Month 12, treatment exposure, and safety over 12 months were reported. Subgroup analysis was conducted on five predefined choroidal neovascularization etiologies (angioid streak, postinflammatory, central serous chorioretinopathy, idiopathic, and miscellaneous).

Results: Ranibizumab showed superior efficacy versus sham from baseline to Month 2 (adjusted least-squares mean best-corrected visual acuity: +9.5 vs. -0.4 letters; P < 0.001). At Month 12, the mean best-corrected visual acuity change was +11.0 letters (ranibizumab) and +9.3 letters (sham). Across the 5 subgroups, the treatment effect ranged from +5.0 to +14.6 letters. The mean number of ranibizumab injections was 5.8 (ranibizumab arm) with no new ocular or nonocular adverse events.

Conclusion: Ranibizumab 0.5 mg resulted in clinically significant treatment effect versus sham at Month 2. Overall, ranibizumab was effective in treating choroidal neovascularization of various etiologies with no new safety findings.

Fig. 1.

Study design (randomized set*). *Consisted of all patients who were randomized. †VA impairment, intraretinal/subretinal fluid presence, hemorrhage, or leakage.

Fig. 2.

Patient disposition (randomized set*). *Consisted of all patients who were randomized.

Fig. 3.

Change in BCVA from baseline to Month 2 (full analysis set* [observed]). *Consisted of all randomized patients to whom treatment regimen has been assigned.

Fig. 4.

Change in BCVA from baseline to Month 2 in each of the specified subgroups (full analysis set* [observed]). *Consisted of all randomized patients to whom treatment regimen has been assigned. †P value is the interaction between the subgroup and treatment; P values > 0.05 are consistent with an equal treatment effect across the subgroup categories. **Etiologies that did not fit into the other CNV etiology subgroups and were insufficiently frequent to form a separate subgroup.

Fig. 5.

Change in BCVA from baseline to Month 12 (full analysis set* [observed]). *Consisted of all randomized patients to whom treatment regimen has been assigned.

Fig. 6.

Change in CSFT from baseline to Month 2 (full analysis set* [observed]). *Consisted of all randomized patients to whom treatment regimen has been assigned.

Fig. 7.

Change in CSFT from baseline to Month 12 (full analysis set* [observed]). *Consisted of all randomized patients to whom treatment regimen has been assigned.

Fig. 8.

Number of injections in the study eye at Month 12 (safety set*). *Consisted of all adult patients who received at least one application of study treatment and had at least one postbaseline safety assessment.