Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

NCT01440751 | Completed Phase 4 DMC

• 1 other identifier: AAE-CT-USA-2010-02
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 8

Brief Summary

The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.

Conditions

Glaucoma

Keywords

ologen collagen matrix; mitomycin-C; trabeculectomy; glaucoma; filtering surgery

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure(IOP) reduction

  "Complete success" is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP. Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size. "Qualified success" that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and "Failure" of meeting the IOP requirements are the other efficacy parameters. In the specified time frame, patients will also visit for record at day 1, 7, 14, 30, 90, 180 days, 12, 18, and 24 months.

  At postoperative up to 24 months.

Secondary Outcomes (1)

• Postoperative complications and appearances

  At postoperative up to 24 months.

Study Arms (2)

ologen Collagen Matrix

EXPERIMENTAL

When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva

Device: Use of ologen Collagen Matrix in trabeculectomy (ologen)

Mitomycin-C (MMC)

ACTIVE COMPARATOR

When performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva

Drug: Use of Mitomycin-C (MMC) in trabeculectomy

Interventions

Use of ologen Collagen Matrix in trabeculectomy (ologen) DEVICE

Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.

ologen Collagen Matrix

Use of Mitomycin-C (MMC) in trabeculectomy DRUG

After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.

Mitomycin-C (MMC)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 30 years (inclusive)
• Uncontrolled treated glaucoma requiring trabeculectomy
• Subject must be able and willing to cooperate with investigation plan
• Subject must be able and willing to complete postoperative follow-up requirements
• subject must be willing to sign informed consent form

You may not qualify if:

• Known allergic reaction to MMC or porcine collagen
• Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery
• Prior cataract unless clear corneal incision
• Previous conjunctival or strabismus surgery
• Participation in an investigational study during 30 days prior to trabeculectomy
• Ocular infection within 14 days prior to trabeculectomy
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Aeon Astron Europe B.V.: lead
• The New York Eye & Ear Infirmary: collaborator
• Robert Ritch, MD, LLC.: collaborator

Study Sites (8)

VoldVision-Holf Eye Clinic

Rogers, Arkansas, 72756, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Institue of Ophthalmology and Visual Science

Newark, New Jersey, 07103, United States

Location

Glaucoma Associates of New York

New York, New York, 10003, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Dean McGee Eye Institue

Oklahoma City, Oklahoma, 73104, United States

Location

Wills Eye Institue

Philadelphia, Pennsylvania, 19107, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location

Related Publications (2)

• Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

  PMID: 36912740 DERIVED

• Tanna AP, Rademaker AW, de Moraes CG, Godfrey DG, Sarkisian SR Jr, Vold SD, Ritch R. Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial. BMC Ophthalmol. 2016 Dec 29;16(1):217. doi: 10.1186/s12886-016-0393-z.

  PMID: 28034308 DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Robert Ritch, MD

  Robert Ritch, MD, LLC.

  PRINCIPAL INVESTIGATOR

• Steven Sarkisian, MD

  Dean McGee Eye Institute

  STUDY DIRECTOR

• Robert Fechtner, MD

  Institute of Ophthalmology and Visual Science

  STUDY DIRECTOR

• Michael Pro, MD

  Wills Eye Institue

  STUDY DIRECTOR

• Steven Vold, MD

  Boozman-Hof Eye Clinic

  STUDY DIRECTOR

• Angelo Tanna, MD

  Northwestern Memorial Hospital

  STUDY DIRECTOR

• David Godfrey, MD

  Glaucoma Associates of Texas

  STUDY DIRECTOR

• Paul Sidoti, MD

  New York Eye and Ear Infirmiry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 27, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)