Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy

NCT03875911 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 17-000432
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

In this Pilot explorative study, the investigators are going to estimate and compare the outcomes of three different delivery methods of MMC for Trabeculectomy: a subconjunctival injection of MMC 0.002% at the site of future Trabeculectomy two to four weeks before the surgery, a subconjunctival injection of MMC 0.01% intraoperatively and topical sponge applied MMC 0.02% intraoperatively (typical use) in patients with Primary Open Angle Glaucoma who did not have any filtering surgeries before. After obtaining informed consent from the patients, the patients are randomly divided into three groups via a block randomization method: Group A receives 0.1 mL MMC 0.002 % (0.1mL MMC 0.02mg/mL) subconjunctival injection preoperatively in superior conjunctiva at the site of future Trabeculectomy surgery. Group B receives 0.1mL MMC 0.01% subconjunctival injection intraoperatively at the site of Trabeculectomy and Group C receives conventional sponge delivery of MMC 0.02% intraoperatively. To avoid observer bias during postoperative evaluation of results, IOP staff obtaining measurements of IOP will be masked to the randomization allocation. All groups undergo conventional Trabeculectomy surgery (fornix-based) as scheduled, and the same routine follow up and post-op regimen will be scheduled for all three groups. Patients are routinely visited in the clinic at first day postoperatively, one week (+/-2 days), one month (+/-1 week), three months (+/-2 weeks), six months (+/-3 weeks) and finally at one year (+/-(4 weeks)). In each of these visits we will be assessing: Visual acuity, intraocular pressure, number and type of glaucoma medication, slit lamp examination of the anterior segment and fundus examination.

Conditions

Glaucoma Open-Angle Primary; Glaucoma; Open Angle Glaucoma; Glaucoma, Open-Angle

Keywords

Trabeculectomy; Mitomycin-C; Glaucoma

Outcome Measures

Primary Outcomes (6)

• IOP - 1 Day Postop

  Mean IOP at 1 day post-operatively

  1 day

• IOP - 1 Week Postop

  Mean IOP at 1 week postop

  1 week

• IOP - 1 Month Postop

  Mean IOP 1 month postoperatively

  1 month

• IOP - 3 Months Postop

  Mean IOP 3 months postoperatively

  3 months

• IOP - 6 Months Postop

  Mean IOP 6 months postoperatively

  6 months

• IOP - 12 Months Postop

  Mean IOP 12 months postoperatively

  12 months

Study Arms (3)

Preoperative Subconjunctival injection of MMC

ACTIVE COMPARATOR

Subconjunctival injection of 0.1 ml of Mitomycin-C 0.002% at the site of future trabeculectomy surgery (2 - 4 weeks preoperatively).

Drug: Mitomycin C

Intraoperative subconjunctival injection of MMC

ACTIVE COMPARATOR

Intraoperative subjconjunctival injection of 0.1 mL of Mitomycin-C 0.01% (0.1mg/mL) to the site of trabeculectomy

Drug: Mitomycin C

Intraoperative topical application of MMC

ACTIVE COMPARATOR

Topical application of Mitomycin-C intraoperatively by applying a sponge soaked in 1mL of Mitomycin-C 0.02 mg/mL for 1 minute to the site of trabeculectomy

Drug: Mitomycin C

Interventions

Mitomycin C DRUG

Three delivery methods of Mitomycin-C in Trabeculectomy

Intraoperative subconjunctival injection of MMC; Intraoperative topical application of MMC; Preoperative Subconjunctival injection of MMC

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20 - 85 years
• Willingness to participate in the study by signing informed consent
• Primary open angle glaucoma (including pigmentary glaucoma and pseudoexfoliation glaucoma) indicated with open angles upon previous gonioscopy and demonstrative optic nerve and visual field damage
• Trabeculectomy needed as treatment as determined by the care provider

You may not qualify if:

• Patient unwilling or unable to give informed consent, unwilling to accept randomization, or unable to return for scheduled study visits throughout the duration of the study (1 year)
• Any secondary cause of glaucoma, or angle closure shown on gonioscopy
• Any ocular or neurological problems with optic nerve or visual field defect (ie. retinal disease, post trauma, corneal scar) that may confound the interpretation of glaucoma such as visual field or optic nerve interpretation
• Pregnant women, nursing women, and/or anyone with a history of allergy to MMC

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (4)

Doheny Eye Center UCLA (Arcadia)

Arcadia, California, 91007, United States

Location

Doheny Eye Center UCLA (Fountain Valley)

Fountain Valley, California, 92708, United States

Location

Stein Eye Institute - UCLA (Westwood)

Los Angeles, California, 90049, United States

Location

Doheny Eye Center UCLA (Pasadena)

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

COVID-19 pandemic occurred during study meaning high rates of patients lost to follow-up, as non-emergent visits were canceled or postponed. This led to early termination which means we had a small number of subjects to analyze, especially those who completed all 12 months of follow-up. By the time pandemic restrictions eased, several other studies had published results on similar trials, making further enrollment unnecessary and further supporting early termination of the study.

Results Point of Contact

• Title: Dr. Joseph Caprioli
• Organization: UCLA Jules Stein Eye Institute

caprioli@jsei.ucla.edu

310-825-6323

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Ophthalmology and David May II Chair in Ophthalmology

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: March 30, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-01

Locations

US (4)