Trials / Completed
CompletedNCT02495181
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
A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of IV Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With PCV.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Association for Innovation and Biomedical Research on Light and Image · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intravitreal Aflibercept |
Timeline
- Start date
- 2015-11-23
- Primary completion
- 2017-08-22
- Completion
- 2019-12-17
- First posted
- 2015-07-13
- Last updated
- 2020-01-10
Locations
13 sites across 2 countries: Portugal, Spain
Source: ClinicalTrials.gov record NCT02495181. Inclusion in this directory is not an endorsement.