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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

1 Aug 2019 → 23 Feb 2025

Decision date (initial)

2024-11-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

External funding

External identifiers

EU CT number

2024-511820-15-03

EudraCT number

2018-001855-10

ClinicalTrials.gov

NCT04054830

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Prophylaxis

The purpose of this 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 or a combination of the two and to explore the mechanisms behind the pathophysiology of glaucoma. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.

Conditions and MedDRA coding

Medically uncontrolled glaucoma that requires filtration surgery.

Regulatory references

Plan to share IPD

Yes

IPD plan description

The results of the study will be presented at international meetings and conferences and published in international, peer-reviewed journals no regards to whether they are positive, negative or inconclusive. Authorship and co-authorship will follow the Vancouver guidelines.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) and ocular hypertension
2. >50 years
3. Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months.
4. Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark
5. Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study
6. Informed consent to participation and ability to comply with study procedures

Exclusion criteria 8

1. Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
2. Prior intraocular surgery, except from cataract surgery
3. Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma
4. Steroid responders
5. Pregnancy
6. Fertile women, i.e. women who are not menopausal and women who breastfeed
7. Patients who are excluded due to perioperative complications will not provide data for the study.
8. Patients in systemic treatment with steroid or NSAID

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.

Secondary endpoints 7

1. Postoperative intraocular pressure at 24 months
2. Best corrected visual acuity (logMAR) at 12 and 24 months
3. Changes in visual field at 12 and 24 months
4. Optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL) by peripapillary optical coherence tomography (OCT) at 12 and 24 months
5. Lens evaluation at, 12- and 24 months by pentacam
6. Bleb morphology at 12 and 24 months
7. Surgical success at 12 and 24 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Valdemar Hansens Vej 1-23

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Øjenforskningen – Center for forskning i Øjensygdomme

Public contact point

Organisation

Rigshospitalet

Contact name

Øjenforskningen – Center for forskning i Øjensygdomme

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications