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

Sponsor

Oslo University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05072262

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) Descemet Membrane Endothelial Keratoplasty (DMEK)	Drug: Nepafenac Ophthalmic Drug: Dexamethasone Ophthalmic	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

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: Nepafenac Ophthalmic Topical nepafenac (Nevanac) 3 mg/ml Drug: Dexamethasone Ophthalmic Topical dexamethasone 1 mg/ml (Spersadex)

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: Nepafenac Ophthalmic

Topical nepafenac (Nevanac) 3 mg/ml

Drug: Dexamethasone Ophthalmic

Topical dexamethasone 1 mg/ml (Spersadex)

Outcome Measures

Primary Outcome Measures

Central macular thickness after 4 weeks [4 weeks after surgery]
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 4 weeks [4 weeks after surgery]
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Oslo University Hospital

Investigators

Principal Investigator: Olav Kristianslund, MD PhD, Department of Ophthalmology, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olav Kristianslund, Principal investigator, Senior consultant MD PhD, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT05072262

Other Study ID Numbers:

131128
2020-003408-15

First Posted:

Oct 8, 2021

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Edema

Dexamethasone

Nepafenac

Study Results

No Results Posted as of Mar 29, 2022