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PRM-151 in the Prevention of Scarring Following Trabeculectomy

NCT01064817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-04-28

Study results available
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Summary

This study will assess the safety and tolerability of PRM-151 administered as a subconjunctival injection and explore the effect of PRM-151 on various correlates of the wound healing process that occurs in the eye after glaucoma filtration surgery.

Conditions

Interventions

DRUG

PRM-151

PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

DRUG

Placebo

Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Edelson, MD, FRCPC, MHSc · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-14
Primary Completion
2012-04-30
Completion
2012-11-14

Countries

  • Belgium
  • Czechia
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01064817 on ClinicalTrials.gov