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GlaucomaPhase 4SNAPNCT04054830

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

A Phase 4 study testing Voltaren Ophtha 1 mg/ml, GSK and Monopex 1 mg/ml, Théa in people with Glaucoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Glaucoma
What is being tested?
Voltaren Ophtha 1 mg/ml, GSK and Monopex 1 mg/ml, Théa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteDenmark
Study dates
1 Aug 2019to Jul 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Ophthalmology

    Glostrup Municipality, Capital Region, 2600

Other trials in Denmark

About this study

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

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.

Read more

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
Being tested
Voltaren Ophtha 1 mg/ml, GSK, Monopex 1 mg/ml, Théa
Keywords
Trabeculectomy, NSAID, Steroid, Anti-Inflammatory Agents, Anti-Inflammatory Agents, Non-Steroidal, Eye Diseases
Medical subject headings
Glaucoma, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Voltaren Ophtha 1 mg/ml, GSKDrug

    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.

  • Monopex 1 mg/ml, ThéaDrug

    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.

Study groups in NCT04054830
Study groupRoleWhat they receive
Topical, preservative-free NSAIDExperimentalTopical 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.
Receives: Drug: Voltaren Ophtha 1 mg/ml, GSK
Topical, preservative-free steroidActive comparatorTopical 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.
Receives: Drug: Monopex 1 mg/ml, Théa
Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSKExperimentalTopical 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
Receives: Drug: Voltaren Ophtha 1 mg/ml, GSK; Drug: Monopex 1 mg/ml, Théa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraocular pressure (IOP)

    Postoperative intraocular pressure (IOP) by applanation tonometry

    Measured: 12 months

Secondary outcomes (4)

  1. Best corrected visual acuity

    Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR)

    Measured: 12 months, 24 months

  2. Visual field

    Postoperative changes in visual field by octopus autoperimetry. (MD)

    Measured: 12 months, 24 months

  3. Optical nerve damage

    Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT)

    Measured: 12 months, 24 months

  4. Surgical success

    The definition of surgical success criteria is dependent on the the severity of visual field defect (MD, mean deviation of visual sensitivity compared to those expected from the age-matched normative database) glaucoma diagnosis and achievement of target pressure without the use of medication (complete success) or with the use of glaucoma medication (qualified success)

    • Ocular hypertension, target <25 mmHg
    • MD < 6 dB, target < 21 mmHg
    • MD 6 dB - 12 dB, target <18 mmHg
    • MD > 12 dB, target < 15 mmHg

    Measured: 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start1 Aug 2019
  3. Primary completion15 Jun 2022
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04054830
Sponsor's protocol ID
EudraCT nr.: 2018-001855-10
Acronym
SNAP
Status last verified
Oct 2022
First submitted
9 Aug 2019
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36602718

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Voltaren Ophtha 1 mg/ml, GSK and Monopex 1 mg/ml, Théa in people with Glaucoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular pressure (IOP) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04054830, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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