Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C

NCT03506542 | Completed Phase 2 FDA Device

• 1 other identifier: not required
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
2. 2.Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
3. 3.Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.

Conditions

Glaucoma; Cataract; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Mean intraocular pressure (IOP) after the surgery

  Decrease in IOP before and after the surgery

  12 months

Secondary Outcomes (3)

• Mean best corrected visual acuity (BCVA) (LogMAR)

  12 months

• Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)

  12 months

• Mean number of antiglaucoma medications

  12 months

Study Arms (2)

Ologen (OLO)

EXPERIMENTAL

Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy

Device: Ologen; Procedure: Phacotrabeculectomy

Mitomycin C (MMC)

ACTIVE COMPARATOR

Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)

Procedure: Phacotrabeculectomy; Drug: Mitomycin C

Interventions

Ologen DEVICE

Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C

Also known as: OLO

Ologen (OLO)

Phacotrabeculectomy PROCEDURE

Trabeculectomy with cataract extraction

Also known as: surgery

Mitomycin C (MMC); Ologen (OLO)

Mitomycin C DRUG

Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)

Also known as: MMC

Mitomycin C (MMC)

Eligibility Criteria

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

You may qualify if:

• Cataract
• Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication

You may not qualify if:

• Difficulty in reading or speaking Polish
• Previous ocular surgery
• Pregnant and breastfeeding women
• Angle closure glaucoma
• Secondary glaucoma except pseudoexfoliation glaucoma
• Ocular diseases with excessive scarring
• Allergy to collagen or Mitomycin C

Sponsors & Collaborators

• Medical University of Lublin: lead
• Aeon Astron Europe B.V.: collaborator

MeSH Terms

Conditions

Glaucoma; Cataract

Interventions

Surgical Procedures, Operative; Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens 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

Study Officials

• Tomasz Żarnowski, MD PhD Prof

  Ophthalmology Clinic, Medical University in Lublin, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, ophthalmologist in Department of Diagnostics and Microsurgery of Glaucoma

Model Details: Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: April 24, 2018
• Study Start: June 2, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 30, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04