Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma

NCT02901236 | Completed Phase 2 DMC

• 1 other identifier: Gl001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Refractory glaucoma often requires vision-sparing trabeculectomy. To increase surgical success, adjunctive pharmacotherapy is utilized albeit the risk of adverse events. This prospective trial randomizes adults with uncontrolled glaucoma to assess an emerging healing modulatory strategy. Over a 1-year follow-up, trabeculectomy complemented with intracameral delivery of anti-angiogenic bevacizumab (1.25 mg) is compared to standard trabeculectomy with anti-fibrotic mitomycin-C (0.02%; applied for 2 minutes).

Conditions

Glaucoma

Keywords

trabeculectomy; glaucoma; filtration surgery; wound healing; angiogenesis; mitomycin; vascular endothelial growth factor inhibition

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  Intraocular pressure measured by Goldmann applanation tonometry was declared the primary outcome measure

  1 year after the intervention

Secondary Outcomes (1)

• Rate of Surgical Success (Survival of Surgical Procedure)

  1 year after the intervention

Study Arms (2)

Mitomycin C

ACTIVE COMPARATOR

Standard Guarded Trabeculectomy will be performed. In this arm 0.02% of mitomycin C (Kyowa, Japan) will be applied on bare sclera under the conjunctiva for 2 minutes. Subsequently, the area will be copiously irrigated with balanced salt solution.

Procedure: Standard Guarded Trabeculectomy; Drug: Mitomycin C

Bevacizumab

ACTIVE COMPARATOR

Standard Guarded Trabeculectomy will be performed. In this arm at the end of the case and after conjunctival closure 1.25mg of bevacizumab (Avastin; Genentech, San Francisco, CA) will be injected into the the anterior chamber through a paracentesis.

Procedure: Standard Guarded Trabeculectomy; Drug: Bevacizumab

Interventions

Standard Guarded Trabeculectomy PROCEDURE

A fornix based conjunctival peritomy is performed. A partial thickness scleral flap is dissected. Then trabeculectomy is performed with a Kelly's punch. A surgical iridectomy is performed. The scleral flap is secured with two pre-placed 8-0 Vicryl sutures (Ethicon, Somerville, NJ). The anterior chamber (AC) is inflated with balanced salt solution and suture tension is adjusted. Finally, conjunctiva is closed with 10-0 running Nylon sutures (Ethicon, Somerville, NJ). Patients receive a subconjunctival injection of 0.4 ml dexamethasone (4 mg/ml) and of 0.4 ml gentamicin (40 mg/ml) at the end of the case. Adjuvant pharmacologic treatment to prevent episcleral fibrosis and failure of the procedure is applied according to treatment arm assignment.

Also known as: trabeculectomy, glaucoma filtration surgery, trabeculectomy with antimetabolites, trabeculectomy with antifibrotic agents

Bevacizumab; Mitomycin C

Mitomycin C DRUG

Sponges soaked in 0.02% mitomycin C (MMC) will be applied on bare sclera for 2 minutes. Subsequently, the area will be copiously irrigated with balanced salt solution.

Also known as: MMC

Mitomycin C

Bevacizumab DRUG

After conjunctival closure 1.25mg of bevacizumab will be injected into the anterior chamber through a paracentesis created earlier during the case.

Also known as: Avastin

Bevacizumab

Eligibility Criteria

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

You may qualify if:

• adult patients
• primary or secondary open angle or angle closure glaucoma
• preoperative intraocular pressure \> 21 mmHg on maximally tolerated medical therapy at least on 2 occasions prior to randomization
• ability to attend regular follow-up

You may not qualify if:

• age (\< 18 years)
• pregnancy
• severe ocular surface disease
• need for combined phacotrabeculectomy
• uveitic or neovascular glaucoma
• any prior intraocular surgery except for uncomplicated phacoemulsification
• a history of a systemic thromboembolic event within 6 months before surgery

Sponsors & Collaborators

• Athens Vision Eye Institute: lead

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy; Antimetabolites; Antifibrotic Agents; Mitomycin; Bevacizumab

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Noxae; Toxic Actions; Anti-Inflammatory Agents; Therapeutic Uses; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gerassimos Kopsinis, M.D., Ph.D.

  Athens Vision Eye Institute

  PRINCIPAL INVESTIGATOR

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: Director of the Glaucoma Service

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 15, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share