Clinical trial • Phase IV • Ophthalmology
Nepafenac for Fuchs dystrophy
Phase IV trial of Nepafenac for Fuchs dystrophy.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Fuchs dystrophy
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 09-09-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
Randomised, two-arm randomized comparison: (1) postoperative topical nsaid (nevanac 3 mg/ml eye drops, suspension; active substance nepafenac; route: ophthalmic; dose unit: gtt drop(s); maxdailydoseamount: 1; maxtotaldoseamount: 42) plus topical steroid (spersadex 1 mg/ml eye drops, solution; active substance dexamethasone; route: ophthalmic; dose unit: gtt drop(s); maxdailydoseamount: 5; maxtotaldoseamount: 1350) versus (2) postoperative topical steroid only (spersadex as above). exact per-arm dosing schedule not further specified in the ctis record.-controlled Phase IV trial across 1 site in Norway.
- Randomised
- Yes
- Comparator
- Two-arm randomized comparison: (1) postoperative topical NSAID (NEVANAC 3 mg/ml eye drops, suspension; active substance nepafenac; route: OPHTHALMIC; dose unit: Gtt drop(s); maxDailyDoseAmount: 1; maxTotalDoseAmount: 42) plus topical steroid (Spersadex 1 mg/ml eye drops, solution; active substance dexamethasone; route: OPHTHALMIC; dose unit: Gtt drop(s); maxDailyDoseAmount: 5; maxTotalDoseAmount: 1350) versus (2) postoperative topical steroid only (Spersadex as above). Exact per-arm dosing schedule not further specified in the CTIS record.
- Target Sample Size
- 120
Eligibility
Recruits 120 Vulnerable population not selected. Participants must be 18 years and older and capable of giving informed consent; no assent procedures or special consent for minors described..
- Pregnancy Exclusion
- • Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding) o Pregnancy or possible pregnancy during the study period is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5
- Vulnerable Population
- Vulnerable population not selected. Participants must be 18 years and older and capable of giving informed consent; no assent procedures or special consent for minors described.
Inclusion criteria
- {"criterion_text":"-•\tPatients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit."}
- {"criterion_text":"-•\tScheduled for DSAEK or DMEK"}
- {"criterion_text":"-•\tAbility to cooperate fairly well during the examinations"}
- {"criterion_text":"-•\tWilling 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
- {"criterion_text":"-•\tContraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding) o\tPregnancy or possible pregnancy during the study period is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5"}
- {"criterion_text":"-•\tPreoperative macular edema and/or ongoing treatment for macular edema"}
- {"criterion_text":"-•\tRe-transplantation"}
- {"criterion_text":"-•\tIn-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)"}
- {"criterion_text":"-•\tAphakic eyes (eyes without a biological or artificial intraocular lens)"}
- {"criterion_text":"-•\tLoss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)"}
Endpoints
Primary endpoints
- {"endpoint_text":"-•\tCentral macular thickness and macular cysts on optical coherence tomography","definition_or_measurement_approach":"Assessment of central macular thickness and macular cysts by optical coherence tomography (OCT)."}
Secondary endpoints
- {"endpoint_text":"-•\tLaser flare","definition_or_measurement_approach":""}
- {"endpoint_text":"-•\tPeroperative factors, e.g. operation time (minutes), iris lesion (none, some, much), pigment loss (none, some, much), intraocular manipulation (none, some, much)","definition_or_measurement_approach":"Peroperative factors recorded (operation time in minutes; categorical grading for iris lesion, pigment loss, and intraocular manipulation as none/some/much)."}
- {"endpoint_text":"-•\tIOP in mmHg (applanation and iCare)","definition_or_measurement_approach":"Intraocular pressure measured in mmHg using applanation tonometry and iCare device."}
- {"endpoint_text":"-•\tCorrected distance visual acuity (in logMAR)","definition_or_measurement_approach":"Corrected distance visual acuity reported in logMAR."}
- {"endpoint_text":"-•\tCorneal endothelial cell density (measured with confocal microscopy, in cells/mm2)","definition_or_measurement_approach":"Corneal endothelial cell density measured with confocal microscopy, reported in cells/mm2."}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 46
- Consent Approach
- Adults (18 years and older) must be willing to participate and capable of giving informed consent. A subject information sheet and adult informed consent form document is listed (L1_SIS and ICF adults). No assent procedures or minor/child consent documents described; languages available are not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 120
Norway
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 15-10-2024
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 120
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Oslo University Hospital, Ophtalmology department
- Contact Person Name
- Olav Kristianslund
- Contact Person Email
- olav.kristianslund@gmail.com
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- NEVANAC 3 mg/ml eye drops, suspension
- Active Substance
- Nepafenac
- Modality
- Small molecule
- Routes Of Administration
- OPHTHALMIC
- Route
- OPHTHALMIC
- Authorisation Status
- Authorised (marketing authorisation EU/1/07/433/002)
- Maximum Dose
- Max daily dose: 1 Gtt drop(s); Max total dose: 42 Gtt drop(s)
- Investigational Product Name
- Spersadex 1 mg/ml øyedråper, oppløsning
- Active Substance
- Dexamethasone
- Modality
- Small molecule
- Routes Of Administration
- OPHTHALMIC
- Route
- OPHTHALMIC
- Authorisation Status
- Authorised (marketing authorisation 5830, country NO)
- Maximum Dose
- Max daily dose: 5 Gtt drop(s); Max total dose: 1350 Gtt drop(s)
- Combination Treatment
- Yes
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