NCT02865031

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 6, 2016

Last Update Submit

August 11, 2016

Conditions

PVR

Outcome Measures

Primary Outcomes (1)

  • Electrophysiological tests ERG a and b implicit time and latency

    3 months

Secondary Outcomes (1)

  • Scar tissue formation graded 0-4 grades

    3 months

Study Arms (1)

Decorin

EXPERIMENTAL

Intravitreal injection of 200-400 ug of Decorin.

Drug: Decorin

Interventions

DecorinDRUG

Intravitreal Injection following ocular trauma to prevent scar tissue formation.

Decorin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: \> 18 years old
  • Perforating Ocular Injuries zone 2 and 3.
  • ERG of the affected eye was at least 50% of the unaffected fellow eye.

You may not qualify if:

  • No concomitant ocular disease.
  • No pervious ocular surgery.
  • No systemic organ failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 11431, Egypt

Location

Related Publications (1)

  • Abdullatif AM, Macky TA, Abdullatif MM, Nassar K, Grisanti S, Mortada HA, Soliman MM. Intravitreal decorin preventing proliferative vitreoretinopathy in perforating injuries: a pilot study. Graefes Arch Clin Exp Ophthalmol. 2018 Dec;256(12):2473-2481. doi: 10.1007/s00417-018-4105-7. Epub 2018 Aug 20.

    PMID: 30128605DERIVED

MeSH Terms

Interventions

Decorin

Intervention Hierarchy (Ancestors)

Chondroitin Sulfate ProteoglycansProteoglycansGlycoproteinsGlycoconjugatesCarbohydratesSmall Leucine-Rich ProteoglycansPolysaccharidesProteinsAmino Acids, Peptides, and ProteinsExtracellular Matrix ProteinsScleroproteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2016

First Posted

August 12, 2016

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

August 12, 2016

Record last verified: 2016-08

Locations

EG(1)