Ahmed Glaucoma Valve Surgery With Mitomycin-C

NCT02805257 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB#16-18935
• Study Type: interventional
• Target: 119
• Locations: 4 countries
• Sites: 4

Brief Summary

This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.

Conditions

Glaucoma; Primary Open Angle Glaucoma; Secondary Glaucoma; Neovascular Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure After Surgery

  Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.

  1 year

Secondary Outcomes (7)

• Intraocular Pressure After Surgery

  6 months

• Number of Medications Postoperatively

  6 months

• Visual Acuity

  6 months

• Number of Medications Postoperatively

  1 year

• Number of Participants With Intraoperative Complications

  Day of Surgery

Study Arms (2)

Mitomycin-C

EXPERIMENTAL

0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.

Drug: Mitomycin-C; Procedure: Ahmed Glaucoma Valve Implant

Balanced Salt Solution (BSS)

PLACEBO COMPARATOR

0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.

Other: Balanced Salt Solution; Procedure: Ahmed Glaucoma Valve Implant

Interventions

Mitomycin-C DRUG

Intraoperative and postoperative injections of mitomycin-c/Mitosol

Also known as: Mitosol

Mitomycin-C

Balanced Salt Solution OTHER

Intraoperative and postoperative injections of BSS

Also known as: BSS

Balanced Salt Solution (BSS)

Ahmed Glaucoma Valve Implant PROCEDURE

Implantation of Ahmed Valve in study eye

Balanced Salt Solution (BSS); Mitomycin-C

Eligibility Criteria

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

You may qualify if:

• Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.
• Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.
• For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.

You may not qualify if:

• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
• Pregnant or nursing women.
• Previous cyclodestruction or glaucoma drainage device (GDD) surgery.
• Patients with nanophthalmos.
• Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
• No light perception vision.
• VA \<20/200 in non-study eye.
• Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
• Previous scleral buckling procedure or silicone oil present.
• Uveitic glaucoma.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Bascom Palmer Eye Institute: collaborator
• University of North Carolina: collaborator
• University of Colorado, Denver: collaborator
• University of Maryland: collaborator
• Zhongshan Ophthalmic Center, Sun Yat-sen University: collaborator
• Asociación para Evitar la Ceguera en México: collaborator
• Hospital Central Militar: collaborator
• Shri Ganesh Vinayak Eye Hospital: collaborator

Study Sites (4)

University of California, San Francisco

San Francisco, California, 94121, United States

Location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Location

Shri Ganesh Vinayak Eye Hospital

Raipur, Chhattisgarh, India

Location

Asociación para Evitar la Ceguera en México (APEC)

Mexico City, Mexico

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular

Interventions

Mitomycin; Hanks Balanced Salt Solution

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

Results Point of Contact

• Title: Ying Han, MD, PhD
• Organization: University of California, San Francisco

ying.han@ucsf.edu

415-476-3321

Study Officials

• Ying Han, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); US (1); IN (1); CN (1)