Clinical trial • Not applicable • Ophthalmology

diclofenac sodium for Macular hole | Vitreomacular traction syndrome | Macular pucker

Not applicable trial of diclofenac sodium for Macular hole | Vitreomacular traction syndrome | Macular pucker.

Overview

Trial Therapeutic Area: Ophthalmology
Trial Disease: Macular hole | Vitreomacular traction syndrome | Macular pucker
Trial Stage: Not applicable
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 30-04-2025
First CTIS Authorization Date: 08-07-2025

Trial design

Test: Dicloabak 1 mg/ml eye drops (diclofenac sodium) — dose units: Gtt drop(s), max daily dose 4 drops, max total dose 168 drops, maxTreatmentPeriod: 6 (timeUnitCode: 2). Comparator: Monofree Dexamethason 1 mg/ml eye drops (dexamethasone phosphate) — dose units: Gtt drop(s), max daily dose 6 drops, max total dose 252 drops, maxTreatmentPeriod: 6 (timeUnitCode: 2). Auxiliary: Volon A 40, Kristallsuspension (triamcinolone acetonide) — suspension for injection, route: SUBCONJUNCTIVAL USE, dose units: mg, max daily dose 20 mg, max total dose 40 mg, maxTreatmentPeriod: 1 (timeUnitCode: 1).-controlled Not applicable trial across 1 site in Belgium.

Comparator: Test: Dicloabak 1 mg/ml eye drops (diclofenac sodium) — dose units: Gtt drop(s), max daily dose 4 drops, max total dose 168 drops, maxTreatmentPeriod: 6 (timeUnitCode: 2). Comparator: Monofree Dexamethason 1 mg/ml eye drops (dexamethasone phosphate) — dose units: Gtt drop(s), max daily dose 6 drops, max total dose 252 drops, maxTreatmentPeriod: 6 (timeUnitCode: 2). Auxiliary: Volon A 40, Kristallsuspension (triamcinolone acetonide) — suspension for injection, route: SUBCONJUNCTIVAL USE, dose units: mg, max daily dose 20 mg, max total dose 40 mg, maxTreatmentPeriod: 1 (timeUnitCode: 1).
Target Sample Size: 120

Eligibility

Recruits 120 No vulnerable populations selected. Consent: "Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"..

Pregnancy Exclusion: Women of childbearing potential , defined as sexually mature females who have not undergone sterilization or are not postmenopausal as per above definition.
Vulnerable Population: No vulnerable populations selected. Consent: "Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures".

Inclusion criteria

{"criterion_text":"- Patients over 18 years of age planned for vitrectomy for macular surgery (macular pucker, vitreomacular traction, macular hole) with/without phaco-emulsification\n- 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).\n- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}

Exclusion criteria

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

Endpoints

Primary endpoints

{"endpoint_text":"- Incidence of an increase of at least 10 mmHg in IOP compared to baseline measured at week 2 and week 8.","definition_or_measurement_approach":"Measured as an increase of at least 10 mmHg in intraocular pressure (IOP) compared to baseline, assessed at week 2 and week 8."}

Secondary endpoints

{"endpoint_text":"- 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","definition_or_measurement_approach":"Assessed by optical coherence tomography (OCT) at month 2 and month 6; includes presence/absence of intraretinal cysts and calculation of ratio (Pre-op subfoveal thickness – Post-op thickness) / Pre-op thickness."}
{"endpoint_text":"- Amount of intra-ocular inflammation measured using laser flare photometry at day 3 (+/_ 2 days), week 2 and week 8.","definition_or_measurement_approach":"Measured by laser flare photometry at specified time points (day 3 ±2 days, week 2, week 8) to quantify postoperative intraocular inflammation."}

Other endpoints

{"endpoint_text":"- The trial includes several exploratory secondary endpoints (e.g., occurrence of CME, postoperative inflammation, subgroup effects) to assess potential trends or clinically relevant signals.","definition_or_measurement_approach":"Exploratory endpoints include occurrence of cystoid macular edema (CME), postoperative inflammation measures and subgroup effect analyses to detect trends or clinically relevant signals; specific measurement methods include OCT and laser flare photometry as described in secondary endpoints."}

Recruitment

Planned Sample Size: 120
Recruitment Window Months: 10
Consent Approach: Voluntary written informed consent is required: "Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures." Participants must be over 18. Available protocol/synopsis documents include English, Dutch (NL), French (FR) and German (DE); informed consent form document available in Dutch (L1_SIS and ICF NL).

Geography

Total Number Of Sites: 1
Total Number Of Participants: 120

Belgium

Earliest CTIS Part Ii Submission Date: 19-06-2025
Latest Decision Or Authorization Date: 08-07-2025
Processing Time Days: 19
Number Of Sites: 1
Number Of Participants: 120

Sites

Site Name: UZ Leuven
Department Name: Ophthalmology
Principal Investigator Name: Peter Stalmans
Principal Investigator Email: peter.stalmans@uzleuven.be
Contact Person Name: Peter Stalmans
Contact Person Email: peter.stalmans@uzleuven.be

Sponsor

Primary sponsor

Full Name: UZ Leuven
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Belgium

Investigational products

Investigational Product Name: Dicloabak 1 mg/ml oogdruppels, oplossing
Active Substance: diclofenac sodium
Modality: Small molecule
Routes Of Administration: OPHTHALMIC USE
Route: OPHTHALMIC USE
Authorisation Status: Marketing authorisation number present (prodAuthStatus 2)
Maximum Dose: 4 Gtt drop(s) per day (maxDailyDoseAmount)

Investigational Product Name: Monofree Dexamethason 1 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik
Active Substance: dexamethasone phosphate
Modality: Small molecule
Routes Of Administration: OPHTHALMIC USE
Route: OPHTHALMIC USE
Authorisation Status: Marketing authorisation number present (prodAuthStatus 2)
Maximum Dose: 6 Gtt drop(s) per day (maxDailyDoseAmount)

Investigational Product Name: Volon A 40, Kristallsuspension
Active Substance: triamcinolone acetonide
Modality: Small molecule
Routes Of Administration: SUBCONJUNCTIVAL USE
Route: SUBCONJUNCTIVAL USE
Authorisation Status: Marketing authorisation number present (prodAuthStatus 2)
Maximum Dose: 20 mg per day (maxDailyDoseAmount)

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