Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective randomised study comparing two intravitreal antiVEGF drugs - brolucizumab and aflibercept - in the treatment of retinal angiomatous proliferation (RAP). Patients with RAP confirmed on optical coherence tomography (OCT) and on OCT angiography (OCTA) will be randomised in two groups and followed for 52 weeks.

Patients in the first group will receive aflibercept - 3 injections monthly for the first 3 months and then in treat-and-extend regimen with minimal interval of 8 weeks and maximal interval of 16 weeks. Extension or shortening of the therapeutic interval will be possible in 2 or 4 week increments based on the visual acuity and disease activity assessed on OCT.

Patients in the second group will receive brolucizumab - 3 injections monthly in the first 3 months and then every 2 or 3 months based on the visual acuity and disease activity assessed on OCT.

Best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT and number of injections will be compared between both groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faculty Hospital Kralovske Vinohrady
• Treatments: Aflibercept; Ranibizumab

Criteria

Inclusion Criteria:

• age of 50 years or more at the time the informed consent is signed

• active RAP in the macula including fovea diagnosed on OCT and OCTA

• BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent)

• decrease in BCVA caused primarily by the RAP in the study eye

• presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT

• patient capable of signing the informed consent

Exclusion Criteria:

• other causes of choroidal neovascular membrane (CNV) than wAMD

• previous or current conditions of the study eye:

1. subretinal haemorrhage comprising more than 25% of the lesion in the study eye

2. scar or fibrosis comprising more than 50% of the lesion in the study eye

3. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye

4. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination

5. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment

6. idiopathic or autoimmune uveitis in the study eye

7. other pathologies in the macula of the study eye which can be expected to influence the BCVA (e.g. macular hole, retinal atrophy, epiretinal membrane, etc.)

8. history of glaucoma surgery in the study eye or probability that it will be necessary in the future

9. aphakia or pseudophakia with absence of the posterior lens capsule (with the exception of missing posterior capsule due to Nd:YAG laser capsulotomy) in the study eye

10. myopia in the study eye with spherical equivalent of more than 8 dioptries before any refractive or cataract surgery

11. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or FP or OCT examination

12. corneal transplantation or corneal dystrophy in the study eye

13. irregular astigmatism or BCVA-lowering amblyopia in the study eye

14. diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye

15. extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit

16. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit

17. allergy or hypersensitivity to any component contained in the study drug

18. pregnant or breastfeeding women