The Effectiveness of Ologen® Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve Surgery (AGV-FP7)

NCT02990143 | Terminated Phase 2

• 1 other identifier: 13.33
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether placing Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• The Effectiveness of ologen® Collagen Matrix in preventing intraocular pressure (IOP) spikes after Ahmed Glaucoma Valve Surgery (AGV-FP7)

  Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

  1 year

Study Arms (2)

Glaucoma Drainage implant no Ologen

NO INTERVENTION

The first group will use the routine technique for glaucoma drainage implant without placement of Ologen.

Glaucoma Drainage implant with Ologen

ACTIVE COMPARATOR

the second group will undergo the same procedure but will have the Ologen placed and secured over the plate of the AGV-FP7, under the conjunctiva, during the surgery.

Procedure: Ologen

Interventions

Ologen PROCEDURE

Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.

Glaucoma Drainage implant with Ologen

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Uncontrolled treated glaucoma requiring AGV-FP7 surgery.
• 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 porcine collagen
• History of uveitis
• Corneal opacity or irregularity, preventing visualization of patency of tip of tube or accurate applanation
• History of scleral buckle

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead

Study Sites (1)

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

collagen-glycosaminoglycan copolymer

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Noga Harizman, MD

  NY Eye Ear

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 13, 2016
• Study Start: January 15, 2014
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (1)