An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic differences, PCV is thought to have a lesser response to anti VEGF therapy which is the mainstay of treatment for other typical wet AMD. Recent trial data suggest that a combination with photodynamic therapy may help in the visual and anatomical outcome of PCV, and emerging evidence shows favourable outcomes the newer anti VEGF agent, aflibercept 2mg monotherapy. These trials however, have assessed aflibercept in a strict 2mg every 8 weekly regime.

In the clinical setting, a significant an unmet need in the management of PCV is a tailored treatment regime. Here we propose a treatment regimen based on disease activity for PCV with aflibercept mono therapy. A limitation of the 2q8 regime is that it is fixed and does not vary regardless of polyp closure or anatomical outcome at the first time point of assessment (month 3). We hypothesize that after the initial 3 monthly injections of aflibercept, about 50% of PCV will close and become quiescent, and in the remaining 50%, a further 3 monthly injections will increase overall polyp closure rate. After a loadings phase of either 3 or 6 months, all eyes will start on a treat and extend regime (T&E), with a minimum period of 8 weeks and a maximum of 12 weeks between treatments with 2 week increments if PCV remains quiescent. The proposed study aims to evaluate the efficacy of a modified treat and extend regime based on disease activity with aflibercept monotherapy for PCV.

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

Details

• Lead Sponsor: Singapore National Eye Centre
• Collaborator: Bayer
• Treatments: Aflibercept

Criteria

Inclusion Criteria Participant

1. Male or female study participants, age >=45 years of age at the time of informed consent.

2. Best corrected ETDRS visual acuity score <= 78 (ie 20/32 or worse)

3. Diagnosis of PCV based on ICGA

1. Presence of intra retinal or subretinal fluid/blood at the fovea as seen on OCT

2. Treatment naïve

4. Media clarity, pupillary dilation and individual cooperation sufficient for study procedure including fundus photography.

5. Able and willing to provide informed consent.

1.2. Exclusion Criteria Participant

1. Medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g.unstable medical status including blood pressure, cardiovascular disease, and glycemic control).

2. Participation in an investigational trial within 30 days of enrolment which involves treatment with unapproved investigational drug

3. Known allergy to any component of the study drug.

4. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110 on repeated measurements). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.

5. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.

6. Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.

Study Eye

1. Eye with intra retinal or subretinal fluid due to other causes than PCV

2. An ocular condition is present (other than PCV) that, in the opinion of the investigator, might affect intra or sub retinal fluid or alter visual acuity during the course of the study (e.g., diabetic macula edema (DME), vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)

3. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by more than three lines (i.e., cataract would be reducing acuity to worse than 20/40 if eye was otherwise normal).

4. Any intraocular surgery within 3 months of enrollment

5. Treatment with intra vitreal corticosteroids

6. History of retinal detachment or surgery for retinal detachment

7. History of vitrectomy

8. History of macular hole

9. Evidence of vitreomacular traction that may preclude resolution of macular edema > 4 disc areas of intra/sub retinal hemorrhage

10. Aphakia

11. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis

Other Eye

1. Active intraocular inflammation

2. History of uveitis