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Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Primary Purpose

Symtomatic Macular Polypoidal Choroidal Vasculopathy

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Intravitreous aflibercept injection

About this trial

This is an interventional treatment trial for Symtomatic Macular Polypoidal Choroidal Vasculopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rajavithi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept

Arm Description

Outcomes

Primary Outcome Measures

Best corrected visual acuity (BCVA)

Secondary Outcome Measures

Full Information

NCT ID

NCT02860858

First Posted

July 4, 2016

Last Updated

October 21, 2020

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02860858

Brief Title

Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Official Title

Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

December 30, 2016 (Actual)

Primary Completion Date

August 30, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symtomatic Macular Polypoidal Choroidal Vasculopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aflibercept

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Intravitreous aflibercept injection

Primary Outcome Measure Information:

Title

Best corrected visual acuity (BCVA)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rajavithi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

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Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

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