NCT04054830: SNAP

Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. An Investigator-initiated Randomized Study (The SNAP Study)

Status unknown Phase 4 Last updated 25 October 2022

What this trial tests

Phase 4 trial testing Voltaren Ophtha 1 mg/ml, GSK in Glaucoma in 70 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
15 June 2022

1 July 2023

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	70
Start date	1 August 2019
Primary completion	15 June 2022
Estimated completion	1 July 2023
Sites	1 location across Denmark

Drugs / interventions tested

• Voltaren Ophtha 1 mg/ml, GSK — full drug profile →
• Monopex 1 mg/ml, Théa — full drug profile →

Conditions studied

• Glaucoma — all drugs for Glaucoma →

Sponsor

Rigshospitalet, Denmark

Who can join

50 and older, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Intraocular pressure (IOP)
  Time frame: 12 months
  Postoperative intraocular pressure (IOP) by applanation tonometry

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early Inflammation Control After Trabeculectomy by Steroid and Non-steroidal Eye Drops: A Randomized Controlled Trial.
   Ahmadzadeh A, Schmidt BS, Bach-Holm D, Kessel L. · · 2023 · cited 3× · PMID 36602718 · DOI 10.1007/s40123-022-00636-2
2. Steroid Response after Trabeculectomy-A Randomized Controlled Trial Comparing Dexamethasone to Diclofenac Eye Drops.
   Ahmadzadeh A, Kessel L, Schmidt BS, Bach-Holm D. · · 2022 · cited 3× · PMID 36555981 · DOI 10.3390/jcm11247365
3. Anterior chamber flare and central macular thickness after trabeculectomy versus after phacoemulsification.
   Ahmed Y, Erichsen JH, Ahmadzadeh A, Holm LM, et al · · 2026 · cited 1× · PMID 41261369 · DOI 10.1111/aos.70032
4. Steroids and/or Non-Steroidal Anti-Inflammatory Drugs as Postoperative Treatment after Trabeculectomy-12-Month Results of a Randomized Controlled Trial.
   Ahmadzadeh A, Kessel L, Schmidt BS, Kolko M, et al · · 2024 · cited 1× · PMID 38337581 · DOI 10.3390/jcm13030887