Brolucizumab in Condor Trial for Proliferative Diabetic Retinopathy

Key Takeaways

• Week 54 visual acuity preservation favored brolucizumab over panretinal photocoagulation.
• No proliferative diabetic retinopathy at week 54 was reported in 63.6% of brolucizumab-treated patients and 22.4% of PRP-treated patients.
• Ocular adverse events were less frequent with brolucizumab overall, while intraocular inflammation including retinal vasculitis was more frequent.

At week 54, brolucizumab 6 mg was associated with a 4.4-letter advantage in best-corrected visual acuity over panretinal photocoagulation in eyes with proliferative diabetic retinopathy. In the phase 3 CONDOR trial, visual acuity preservation favored brolucizumab at the prespecified primary timepoint. Retinopathy control and ocular safety findings also differed between groups.

The CONDOR randomized clinical trial was a 96-week, 2-arm, single-masked, multicenter, phase 3 study conducted across 16 countries and 152 sites. Eligible patients had diabetes, proliferative diabetic retinopathy, and no previous panretinal photocoagulation in the study eye. A total of 689 participants were randomized, with 347 assigned to brolucizumab and 342 to PRP. Brolucizumab 6 mg was given as 3 loading doses every 6 weeks, then every 12 weeks, with optional 6-week interval extensions from week 48 up to 24 weeks based on disease activity. PRP was delivered in 1 to 4 sessions up to week 12, with additional PRP as needed. The primary outcome was change from baseline in best-corrected visual acuity at week 54, and secondary outcomes included diabetic retinopathy progression, prevention of center-involved diabetic macular edema, change in Diabetic Retinopathy Severity Score levels, and safety.

Among 572 randomized participants who completed the week 54 visit, least-squares mean best-corrected visual acuity change was 0.2 letters with brolucizumab and minus 4.2 letters with PRP. The between-group difference was 4.4 letters, with a 95% CI of 2.4 to 6.4 and P < .001. Investigators described brolucizumab as both noninferior and superior to PRP for this primary outcome. Retinopathy control also favored brolucizumab at week 54, consistent with the higher proportion of eyes without proliferative diabetic retinopathy.

Ocular adverse events were reported in 34.3% of the brolucizumab group and 49.1% of the PRP group. Intraocular inflammation, including retinal vasculitis, was reported in 5.2% and 0.6%, respectively. The safety findings showed fewer ocular adverse events overall with brolucizumab but more intraocular inflammation.

The authors concluded that brolucizumab was superior to PRP in preserving visual acuity and may represent a viable treatment alternative to PRP monotherapy for patients with proliferative diabetic retinopathy. That interpretation was limited to the reported trial findings and the week 54 efficacy assessment. Trial registration was listed as ClinicalTrials.gov identifier NCT04278417.