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Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy

NCT02495181 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-10

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).

Conditions

  • Polypoidal Choroidal Vasculopathy

Interventions

DRUG

Intravitreal Aflibercept

Sponsors & Collaborators

  • European Vision Institute Clinical Research Network

    collaborator NETWORK

  • Association for Innovation and Biomedical Research on Light and Image

    lead OTHER

Principal Investigators

  • Rufino Silva, PhD · Association for Innovation and Biomedical Research on Light and Image

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-23
Primary Completion
2017-08-22
Completion
2019-12-17

Countries

  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02495181 on ClinicalTrials.gov