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Dacorin for Proliferative Vitreoretinopathy

NCT02865031 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-08-12

No results posted yet for this study

Summary

Purpose: To determine the safety, tolerability, and efficacy of human recombinant decorin protein, a transforming growth factor ß (TGFß) inhibitor in preventing proliferative vitreoretinopathy (PVR) in patients with perforating globe injuries.

Methods: This is a prospective, single-center, open-label, interventional case series. A single intravitreal injection of decorin 200ug (n=4) and 400ug (n=8) was given within 24 hours of injury. Pars plana vitrectomy with silicone oil injection was done if indicated. ERG was done before injections, at day 10, and 3 months. Serial plasma decorin levels were assessed before injections, day 3, 5, and 10 post-injection. Clinical assessment included globe survival, retinal attachment rate, and PVR evaluation.

Conditions

  • PVR

Interventions

DRUG

Decorin

Intravitreal Injection following ocular trauma to prevent scar tissue formation.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • Egypt

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 NCT02865031 on ClinicalTrials.gov