Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Phase 4

Completed

• Conditions: Symtomatic Macular Polypoidal Choroidal Vasculopathy
• Interventions: Biological: Intravitreous aflibercept injection

• Registration Number: NCT02860858
• Lead Sponsor: Rajavithi Hospital

Brief Summary

Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-09
• Study Start: 2016-12-30
• Status Verified: 2018-05
• Primary Completion: 2018-08-30
• Study Completion: 2018-12-31
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male or Female >/= 18 years
• Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy
• BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters

Exclusion Criteria

• Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])

Study eye:

• Active ocular inflammation or infection (ocular or periocular)
• Uncontrolled intraocular hypertension or glaucoma (IOP> 30 mmPIg) despite treatment with anti-glaucoma medication
• Predominantly-scarred PCV lesions
• Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period
• Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
• Prior treatment with any anti-VEGF compound or any investigational treatment
• Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept	Intravitreous aflibercept injection	-

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA)	2 years

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand