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

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 (DMEC)

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).

Study Overview

• Status: Recruiting
• Conditions: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK); Descemet Membrane Endothelial Keratoplasty (DMEK)
• Intervention / Treatment: Drug: Dexamethasone Ophthalmic; Drug: Nepafenac Ophthalmic

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Department of Ophthalmology, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control (dexamethasone only); Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery	Drug: Dexamethasone Ophthalmic; Topical dexamethasone 1 mg/ml (Spersadex)
EXPERIMENTAL: Study group (NSAIDs and dexamethasone); Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.	Drug: Dexamethasone Ophthalmic; Topical dexamethasone 1 mg/ml (Spersadex); Drug: Nepafenac Ophthalmic; Topical nepafenac (Nevanac) 3 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular inflammation	Measured by laser flare meter	Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Intraocular pressure	Measured by tonometry	Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery
Visual outcome	Measure uncorrected and corrected distance visual acuity using visual acuity chart	Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Corneal endothelial status	Measure corneal endothelial cell density using microscopy instrument	1 week, 4 weeks, 2 months and 2 years after surgery
Patient reported outcome measure (PROM)	COMToL questionnaire for ocular medication	1 week, 4 weeks and 2 months after surgery
Central macular thickness (CMT)	Measure CMT (in um) on optical coherence tomography (OCT)	Preoperatively, and 1 week, 2 months, and 2 years after surgery
Cystoid macular edema (CME)	Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)	Preoperatively, and 1 week, 2 months, and 2 years after surgery

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2022
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): October 1, 2026

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (ACTUAL): October 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Nepafenac
• Other Study ID Numbers: 131128; 2020-003408-15 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No