DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)

NCT05072262 | Recruiting Phase 4

• 2 other identifiers: 1311282020-003408-15
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).

Conditions

Descemet Stripping Automated Endothelial Keratoplasty (DSAEK); Descemet Membrane Endothelial Keratoplasty (DMEK)

Outcome Measures

Primary Outcomes (2)

• Central macular thickness after 4 weeks

  Measure central macular thickness (in um) on optical coherence tomography (OCT)

  4 weeks after surgery

• Cystoid macular edema (CME) after 4 weeks

  Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

  4 weeks after surgery

Secondary Outcomes (7)

• Intraocular inflammation

  Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery

• Intraocular pressure

  Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery

• Visual outcome

  Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery

• Corneal endothelial status

  1 week, 4 weeks, 2 months and 2 years after surgery

• Patient reported outcome measure (PROM)

  1 week, 4 weeks and 2 months after surgery

Study Arms (2)

Control (dexamethasone only)

ACTIVE COMPARATOR

Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Drug: Dexamethasone Ophthalmic

Study group (NSAIDs and dexamethasone)

EXPERIMENTAL

Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.

Drug: Nepafenac Ophthalmic; Drug: Dexamethasone Ophthalmic

Interventions

Nepafenac Ophthalmic DRUG

Topical nepafenac (Nevanac) 3 mg/ml

Study group (NSAIDs and dexamethasone)

Dexamethasone Ophthalmic DRUG

Topical dexamethasone 1 mg/ml (Spersadex)

Control (dexamethasone only); Study group (NSAIDs and dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
• Scheduled for DSAEK or DMEK
• Ability to cooperate fairly well during the examinations
• Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
• Pregnancy or possible pregnancy during the study period
• Preoperative macular edema and/or ongoing treatment for macular edema
• Re-transplantation
• In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
• Aphakic eyes (eyes without a biological or artificial intraocular lens)
• Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Ophthalmology, Oslo University Hospital

Oslo, Norway

RECRUITING

Study Officials

• Olav Kristianslund, MD PhD

  Department of Ophthalmology, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olav Kristianslund, MD PhD

CONTACT

+4722118545; olakri@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Senior consultant MD PhD

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 8, 2021
• Study Start: November 25, 2022
• Primary Completion: June 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

NO (1)