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An Open-Label Investigator Sponsored Trial to Investigate the Safety, Tolerability and Development of Subfoveal Fibrosis By Intravitreal Administration of Altering Regimens of Fovista and Anti-VEGF Therapy in Subjects With Neovascular Age-Related Macular Degeneration

NCT02591914 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-09-24

No results posted yet for this study

Summary

The objectives of this study are to establish the safety and tolerability of intravitreous administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with subfoveal neovascular age-related macular degeneration.

Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three months. Retreatment with Fovista™ and Anti-VEGF will occur if the following findings are present PER INVESTIGATOR DISCRETION:

* ≥ 5 ETDRS letters loss OR;
* Significant hemorrhage OR;
* New or increased RPE elevation consistent with increased disease activity OR;
* Increased neovascular lesion size OR;
* New or increased foveal intraretinal fluid

If anti-VEGF re-treatment is not administered based on the re-treatment criteria noted above, Fovista™ anti-PDGF therapy MUST be administered at a minimum of every 3 months (as monotherapy).

Therefore, subjects will be treated with Fovista™ or Anti-VEGF therapy for a total of 3-24 administrations.

Conditions

  • Neovascular Age-Related Macular Degeneration

Interventions

DRUG

Fovista™

Anti-PDGF-B pegylated aptamer

DRUG

Lucentis®

Anti-VEGF

DRUG

Avastin®

Anti-VEGF

DRUG

Eylea®

Anti-VEGF

Sponsors & Collaborators

  • Ophthotech Corporation

    collaborator INDUSTRY

  • Retinal Consultants of Arizona

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-05-18
Completion
2016-05-24

Countries

  • United States

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 NCT02591914 on ClinicalTrials.gov