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Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860858
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Symtomatic Macular Polypoidal Choroidal Vasculopathy Biological: Intravitreous aflibercept injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)
Actual Study Start Date : December 30, 2016
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aflibercept Biological: Intravitreous aflibercept injection



Primary Outcome Measures :
  1. Best corrected visual acuity (BCVA) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860858


Locations
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Thailand
Rajavithi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT02860858    
Other Study ID Numbers: 18265_CREC032/59BPs
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: May 2018
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases