Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy.

NCT04054830 | Unknown Phase 4 DMC

• 1 other identifier: EudraCT nr.: 2018-001855-10
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: Glaucoma is the leading cause of non-curable blindness globally. Patients with glaucoma will get a gradual narrowing of the visual fields caused by compression at the optic nerve head due to increased intraocular pressure. Thus the main preventive strategy is to reduce intraocular pressure, initially by eye drops and/or laser treatment but in some patients surgery is warranted. The surgical procedure (trabeculectomy) most widely performed worldwide creates a path from the anterior chamber to the subconjunctival space and thereby lowers the IOP by producing a more efficient drainage of the aqueous humour. Surgical success depends upon controlling post-operative inflammation to ensure a functional drainage. The purpose of this blinded, randomized study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids. Additionally, we want to explore the mechanisms behind the pathophysiology of glaucoma by evaluating retinal and optic nerve head perfusion before and after IOP lowering surgery. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry. MAIN HYPOTHESIS:

• NSAIDs and steroids are equally effective in assuring long-term filtering function and controlling IOP after trabeculectomy but may be associated with different risk profiles and bleb morphology
• Patients with lower post-operative IOP demonstrate less progression of visual field loss
• Trabeculectomy lowers IOP and provides better microcirculation in and oxygenation of inner retinal layers (i.e. ganglion cell layer) and the optic nerve head

Conditions

Glaucoma

Keywords

Trabeculectomy; NSAID; Steroid; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  Postoperative intraocular pressure (IOP) by applanation tonometry

  12 months

Secondary Outcomes (4)

• Best corrected visual acuity

  12 months, 24 months

• Visual field

  12 months, 24 months

• Optical nerve damage

  12 months, 24 months

• Surgical success

  12 months, 24 months

Study Arms (3)

Topical, preservative-free NSAID

EXPERIMENTAL

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Drug: Voltaren Ophtha 1 mg/ml, GSK

Topical, preservative-free steroid

ACTIVE COMPARATOR

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Drug: Monopex 1 mg/ml, Théa

Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK

EXPERIMENTAL

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per wee

Drug: Voltaren Ophtha 1 mg/ml, GSK; Drug: Monopex 1 mg/ml, Théa

Interventions

Voltaren Ophtha 1 mg/ml, GSK DRUG

Voltaren Ophtha 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Topical, preservative-free NSAID; Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK

Monopex 1 mg/ml, Théa DRUG

Monopex 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK; Topical, preservative-free steroid

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) or ocular hypertension
• \>50 years
• Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months
• Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark
• Informed consent to participation and ability to comply with study procedures

You may not qualify if:

• Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
• Prior intraocular surgery, except from cataract surgery. If cataract surgery has been performed, it should at least be 6 months prior to surgery
• Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma
• Steroid responders
• Pregnancy
• Fertile women, i.e. women who are not menopausal and women who breastfeed
• Patients in systemic treatment with steroid or NSAID

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Ophthalmology

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Related Publications (1)

• Ahmadzadeh A, Schmidt BS, Bach-Holm D, Kessel L. Early Inflammation Control After Trabeculectomy by Steroid and Non-steroidal Eye Drops: A Randomized Controlled Trial. Ophthalmol Ther. 2023 Apr;12(2):969-984. doi: 10.1007/s40123-022-00636-2. Epub 2023 Jan 5.

  PMID: 36602718 DERIVED

MeSH Terms

Conditions

Glaucoma; Eye Diseases

Interventions

halofantrine

Condition Hierarchy (Ancestors)

Ocular Hypertension

Study Officials

• Daniella Bach-Holm, MD, Ph.D.

  Dpt. of Ophthalmology, Rigshospitalet-Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: August 1, 2019
• Primary Completion: June 15, 2022
• Study Completion: July 1, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

DK (1)