Comparing postoperative recovery after vitrectomy using NSAID eyedrops versus steroid eyedrops

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

1 Sep 2025 → ongoing

Decision date (initial)

2025-07-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Théa Pharma NV: research grant

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacodynamic

To prove a reduced occurrence of post-operative increased intra-ocular pressure when using NSAID drops instead of steroid drops after vitrectomy.

Secondary objectives 5

1. The trial includes several exploratory secondary endpoints (e.g., occurrence of CME, postoperative inflammation, subgroup effects) to assess potential trends or clinically relevant signals.
2. The occurrence and severity of CME will be assessed using optical coherence tomography (OCT) at 2 and 6 months postoperatively. The endpoint includes presence or absence of intraretinal cysts and quantitative changes in subfoveal thickness
3. To evaluate the influence of laser photocoagulation, the relationship between the amount of photocoagulation applied and the level of postoperative inflammation and occurrence of CME will be analyzed
4. Subgroup analyses will be conducted to explore whether the effect of treatment differs between patients undergoing combined cataract surgery (phaco-vitrectomy) versus those undergoing vitrectomy alone. All primary and secondary endpoints will be descriptively compared within these subgroups, and interaction effects may be explored where appropriate
5. Postoperative intraocular inflammation will be measured by laser flare photometry at multiple time points (day 2–5, week 2, and week 8).

Conditions and MedDRA coding

Macular hole

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients over 18 years of age planned for vitrectomy for macular surgery (macular pucker, vitreomacular traction, macular hole) with/without phaco-emulsification
2. Female participants must be either postmenopausal (no menses for ≥12 consecutive months without alternative medical cause) or surgically sterile (e.g., bilateral oophorectomy or hysterectomy).
3. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

Exclusion criteria 9

1. Participant has a history of other retinal disease that may affect the formation of macular edema
2. Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
3. Ocular hypertension (IOP > 21 mmHg) and/or glaucoma
4. Systemic steroid or NSAID or immunosuppressant use
5. Recent intra-ocular surgery (phaco-emulsification) < 6 months
6. Previous vitrectomy surgery in study eye
7. Women of childbearing potential , defined as sexually mature females who have not undergone sterilization or are not postmenopausal as per above definition.
8. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
9. Hypersensitivity towards diclofenac and one of the excipients of the finished product

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of an increase of at least 10 mmHg in IOP compared to baseline measured at week 2 and week 8.

Secondary endpoints 2

1. Amount and grading of macular oedema on OCT at month 2 and 6 after surgery: - Presence or absence of intra-retinal cysts - Ratio of (Pre-op subfoveal thickness – Post-op thickness) / Pre-op thickness
2. Amount of intra-ocular inflammation measured using laser flare photometry at day 3 (+/_ 2 days), week 2 and week 8.

Investigational products

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

Test 1

Comparator 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Ophthalmology department information desk

Public contact point

Organisation

UZ Leuven

Contact name

Ophthalmology department information desk

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 9 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