NCT03766425

Brief Summary

Comparison of efficacy and safety of Mitomycin and Aflibercept used to support primary trabeculectomy - a prospective, randomized trial in patients with open-angle glaucoma undergoing surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2017

Typical duration for early_phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

2.1 years

First QC Date

November 25, 2018

Last Update Submit

October 26, 2023

Conditions

Eye DiseasesOptic Nerve DamageGlaucoma Surgery

Keywords

afliberceptglaucomamitomycintrabeculectomy

Outcome Measures

Primary Outcomes (2)

  • Effectiveness of aflibercept and mitomycin on the morphology of the bleb;

    Rating the bleb in The Indiana Bleb Appearance Grading Scale, describing bleb height, extent, vascularity, and leakage with the Seidel test.

    1 year

  • Effectiveness of aflibercept and mitomycin on the function of the bleb;

    Measurement of intraocular pressure (Goldmann applanation tonometer) and taking a photo of a bleb.

    1 year

Secondary Outcomes (4)

  • Impact of tested substances on visual acuity after surgery

    1 year

  • The influence of aflibercept and mitomycin on corneal endothelial cell density after surgery

    1 year

  • Impact of used substances on visual field parameters

    1 year

  • Frequencies and type of possible complications.

    1 year

Study Arms (2)

Aflibercept

EXPERIMENTAL

Aflibercept applied intraoperatively as a subconjunctival injection at a dose of 0.05 ml (40 mg / ml) and one week after the operation at the same dose, also subconjunctival.

Drug: Aflibercept

Mitomycin

ACTIVE COMPARATOR

Mitomycin applied during a surgery at a concentration of 0.3mg / ml for 3 min. on a soaked sponge.

Drug: Mitomycin

Interventions

AfliberceptDRUG

subconjunctival injection

Also known as: Eylea, Zaltrap
Aflibercept
MitomycinDRUG

subconjunctival injection

Also known as: Ametycine, Mit-C, Mitomycin C
Mitomycin

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary open-angle glaucoma or capsular glaucoma.
  • Patient's age: over 40 years, no sex preference;
  • Local treatment ineffective due to:
  • Intraocular pressure above 21mmHg at maximum pharmacological therapy (using β-blocker + carbonic anhydrase inhibitor + prostaglandins) or
  • Intolerance to topical treatment or
  • Progression in visual field examination
  • Lack of previous ophthalmological surgical interventions.
  • Lack of previously performed laser gonioplasty.
  • No laser trabeculoplasty or laser trabeculoplasty performed for more than a year.

You may not qualify if:

  • Patient with primary closed-angle glaucoma or secondary glaucoma (except for glaucoma in the course of pseudoexfoliation syndrome).
  • One-eye patient.
  • Patient with aphakia.
  • Patient after previous ophthalmic procedures (cataract removal by phacoemulsification with an implant of an intraocular lens, vitrectomy by pars plana, keratoplasty).
  • A patient diagnosed or suspected of having uveitis or intraocular inflammation.
  • Any corneal abnormalities or other conditions that prevent reliable testing with an applanation device in the treated eye, including earlier refractive surgery of the eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lublin

Lublin, Lublin Voivodeship, 20-059, Poland

Location

MeSH Terms

Conditions

Eye DiseasesOptic Nerve InjuriesGlaucoma

Interventions

afliberceptMitomycin

Condition Hierarchy (Ancestors)

Cranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesOcular Hypertension

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tomasz Żarnowski, PhD

    Medical Uniwersity of Lublin al. Racławickie 1 20-059 Lublin

    STUDY DIRECTOR

  • Justyna Kaproń-Swiś, MD

    Medical Uniwersity of Lublin al. Racławickie 1 20-059 Lublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 25, 2018

First Posted

December 6, 2018

Study Start

June 14, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)