HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration.

Purpose: Two similarly designed phase 3 trials (HAWK and HARRIER) compared brolucizumab, a single-chain antibody fragment that inhibits vascular endothelial growth factor-A, with aflibercept to treat neovascular age-related macular degeneration (nAMD).

Design: Double-masked, multicenter, active-controlled, randomized trials.

Participants: Patients (N = 1817) with untreated, active choroidal neovascularization due to age-related macular degeneration in the study eye.

Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial.

Purpose: To compare the efficacy and safety of brolucizumab with aflibercept to treat neovascular age-related macular degeneration (AMD).

Design: Prospective, randomized, double-masked, multicenter, 2-arm, phase 2 study.

Participants: Eighty-nine treatment-naïve participants, aged ≥50 years, with active choroidal neovascularization secondary to AMD.

Single-Chain Antibody Fragment VEGF Inhibitor RTH258 for Neovascular Age-Related Macular Degeneration: A Randomized Controlled Study.

Purpose: To assess the safety and efficacy of different doses of RTH258 applied as single intravitreal administration compared with ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (AMD).

Design: Six-month, phase 1/2, prospective, multicenter, double-masked, randomized, ascending single-dose, active-controlled, parallel-group study.

Outcomes following three-line vision loss during treatment of neovascular age-related macular degeneration: subgroup analyses from MARINA and ANCHOR.

Aim: This study aims to assess the impact of continued ranibizumab treatment for neovascular age-related macular degeneration on patients from the MARINA and ANCHOR randomised clinical studies who lost ≥ 3 lines of best-corrected visual acuity (BCVA) at any time during the first year of treatment.

Methods: Baseline characteristics, mean BCVA over time and ocular adverse events (AEs) were evaluated both for patients whose BCVA loss occurred at any post-baseline visit and for patients whose BCVA loss was acute. The visit when the ≥ 3-line BCVA loss was detected was defined as the new baseline.

Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN study.

Objective: To evaluate the safety and efficacy of individualized ranibizumab treatment in patients with neovascular age-related macular degeneration.

Design: Twelve-month, phase III, multicenter, open-label, single-arm study.

Participants: A total of 513 ranibizumab-naïve SUSTAIN patients.

The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema.

Objective: To demonstrate superiority of ranibizumab 0.5 mg monotherapy or combined with laser over laser alone based on mean average change in best-corrected visual acuity (BCVA) over 12 months in diabetic macular edema (DME).

Design: A 12-month, randomized, double-masked, multicenter, laser-controlled phase III study.

Efficacy and safety of monthly versus quarterly ranibizumab treatment in neovascular age-related macular degeneration: the EXCITE study.

Objective: To demonstrate noninferiority of a quarterly treatment regimen to a monthly regimen of ranibizumab in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Design: A 12-month, multicenter, randomized, double-masked, active-controlled, phase IIIb study.

Participants: Patients with primary or recurrent subfoveal CNV secondary to AMD (353 patients), with predominantly classic, minimally classic, or occult (no classic component) lesions.

Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study.

Objective: The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center.

The effects of a flexible visual acuity-driven ranibizumab treatment regimen in age-related macular degeneration: outcomes of a drug and disease model.

Purpose: Differences in treatment responses to ranibizumab injections observed within trials involving monthly (MARINA and ANCHOR studies) and quarterly (PIER study) treatment suggest that an individualized treatment regimen may be effective in neovascular age-related macular degeneration. In the present study, a drug and disease model was used to evaluate the impact of an individualized, flexible treatment regimen on disease progression.

Methods: For visual acuity (VA), a model was developed on the 12-month data from ANCHOR, MARINA, and PIER.