NCT03924544

Brief Summary

This is a prospective, single-center, interventional, randomized controlled study comparing Decorin as antifibrotic agent in sub scleral trabeculectomy versus Mitomycin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 18, 2019

Last Update Submit

April 19, 2019

Conditions

Primary Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • success of trabeculectomy

    complete if the IOPis≤ 21 mm Hg without medications

    one year

Study Arms (2)

Decorin Group

EXPERIMENTAL

26 patients will receive subconjunctival injection of 100 µg decorin 15 minutes before surgery, 1, 3, and 7postoperatively. A30-gauge needle was used to inject 100 µL of decorin. The needle was placed at the nasal margin of the superior rectus muscle

Drug: Decorin

Mitomycin Group

ACTIVE COMPARATOR

MMC will then be applied in 26 patients to the sclera at a concentration of 0.3 mg/ml using cellulose sponges, which will be removed after 3 minutes followed by copious irrigation with balanced saline solution (BSS).

Drug: Mitomycin c

Interventions

DecorinDRUG

Antifibrotic agent

Decorin Group
Mitomycin cDRUG

Antifibrotic agent

Mitomycin Group

Eligibility Criteria

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

You may qualify if:

  • Primary Open Angle Glaucoma

You may not qualify if:

  • Secondary Glaucoma, Closed angle glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (3)

  • 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: 30128605BACKGROUND

  • Grisanti S, Szurman P, Warga M, Kaczmarek R, Ziemssen F, Tatar O, Bartz-Schmidt KU. Decorin modulates wound healing in experimental glaucoma filtration surgery: a pilot study. Invest Ophthalmol Vis Sci. 2005 Jan;46(1):191-6. doi: 10.1167/iovs.04-0902.

    PMID: 15623773BACKGROUND

  • Nassar K, Luke J, Luke M, Kamal M, Abd El-Nabi E, Soliman M, Rohrbach M, Grisanti S. The novel use of decorin in prevention of the development of proliferative vitreoretinopathy (PVR). Graefes Arch Clin Exp Ophthalmol. 2011 Nov;249(11):1649-60. doi: 10.1007/s00417-011-1730-9. Epub 2011 Jul 7.

    PMID: 21735240BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

DecorinMitomycin

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Chondroitin Sulfate ProteoglycansProteoglycansGlycoproteinsGlycoconjugatesCarbohydratesSmall Leucine-Rich ProteoglycansPolysaccharidesProteinsAmino Acids, Peptides, and ProteinsExtracellular Matrix ProteinsScleroproteinsMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 23, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)