Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

R

Rajavithi Hospital

Status and phase

Completed
Phase 4

Conditions

Symtomatic Macular Polypoidal Choroidal Vasculopathy

Treatments

Biological: Intravitreous aflibercept injection

Study type

Interventional

Funder types

Other

Identifiers

NCT02860858
18265_CREC032/59BPs

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Aflibercept
Experimental group
Treatment:
Biological: Intravitreous aflibercept injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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