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OpenTrials
Completed

NCT Number: NCT02860858

Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreous aflibercept injection

Biological

Primary outcomes

  1. Best corrected visual acuity (BCVA)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2016
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.