An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED

Part of paid clinical trials in Huntington Beach, California.

Sponsor
Dompé Farmaceutici S.p.A
Study ID
NCT07519902
Phase
PHASE3
Status
Recruiting
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Conditions

  • Persistent Corneal Epithelial Defect

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cenegermin — DRUG
    Cenegermin is administered topically.
  • Vehicle — OTHER
    Vehicle is administered topically.

Study Details

This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants with PCED. The primary objective is the evaluation of complete epithelial healing after 4 weeks of treatment. The study is comprised of 3 periods: an 8-week initial treatment period (Day 1 to Week 8), an 8-week extension treatment period (Week 9 to Week 16), and a 24-week follow-up period (Week 17 to Week 40).

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cenegermin
    Participants will be randomized to receive cenegermin ophthalmic solution in the study eye.
  • Placebo Comparator: Vehicle
    Participants will be randomized to receive vehicle ophthalmic solution in the study eye.

Primary Outcome Measure

Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8 [ Time Frame: At Weeks 4 and 8 ]

Central Contacts

  • Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
    +39 02 583 831

Locations (18)

FacilityCityStateZIPSite coordinators
Azul Vision, INCHuntington BeachCalifornia92647-
Harvard Eye AssociatesLaguna HillsCalifornia92653-
Loma Linda University Adventist Health Sciences CenterLoma LindaCalifornia92354-
UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye DiseLos AngelesCalifornia90095-
California Eye Specialists Medical Group, Inc.RedlandsCalifornia92373-
East Coast Institute for Research - Florida Eye SpecialistsJacksonvilleFlorida32207-
Bascom Palmer Eye Institute, University of Miami School of MedicineMiamiFlorida33136-
University of South FloridaTampaFlorida33620-
Massachusetts Eye and EarBostonMassachusetts02114-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
University of Michigan Health - Kellogg Eye CenterAnn ArborMichigan48105-
Midwest Vision Research FoundationChesterfieldMissouri63017-
NYU Langone Eye Center (Ophthalmology)New YorkNew York10017-
Duke Eye Center - OphthalmologyDurhamNorth Carolina27705-
Vance Thompson Vision - Sioux FallsSioux FallsSouth Dakota57108-
Houston Eye Associates (HEA)HoustonTexas77030-
The Eye Institute of UtahSalt Lake CityUtah84107-
Virginia Eye ConsultantsNorfolkVirginia23502-

Find similar trials in Huntington Beach, CA

By research site
Azul Vision, INC· Huntington Beach, CAHarvard Eye Associates· Laguna Hills, CALoma Linda University Adventist Health Sciences Center· Loma Linda, CAUCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye Dise· Los Angeles, CACalifornia Eye Specialists Medical Group, Inc.· Redlands, CAEast Coast Institute for Research - Florida Eye Specialists· Jacksonville, FL

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