Overview
Sponsor-declared trial summary
Fuchs dystrophy
Compare central macular thickness and the risk of cystoid macular edema between two medication regimens after corneal endothelial transplantation
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 2 Dec 2022 → ongoing
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510091-31-00
- EudraCT number
- 2020-003408-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Compare central macular thickness and the risk of cystoid macular edema between two medication regimens after corneal endothelial transplantation
Conditions and MedDRA coding
Fuchs dystrophy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- • 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 6
- • 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
- • 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)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Central macular thickness and macular cysts on optical coherence tomography
Secondary endpoints 5
- • Laser flare
- • Peroperative factors, e.g. operation time (minutes), iris lesion (none, some, much), pigment loss (none, some, much), intraocular manipulation (none, some, much)
- • IOP in mmHg (applanation and iCare)
- • Corrected distance visual acuity (in logMAR)
- • Corneal endothelial cell density (measured with confocal microscopy, in cells/mm2)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
NEVANAC 3 mg/ml eye drops, suspension
PRD5040925 · Product
- Active substance
- Nepafenac
- Pharmaceutical form
- EYE DROPS, SUSPENSION
- Route of administration
- OPHTHALMIC
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 42 Gtt drop(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01BC10 — -
- Marketing authorisation
- EU/1/07/433/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Spersadex 1 mg/ml øyedråper, oppløsning
PRD9120412 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OPHTHALMIC
- Max daily dose
- 5 Gtt drop(s)
- Max total dose
- 1350 Gtt drop(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01BA01 — DEXAMETHASONE
- Marketing authorisation
- 5830
- MA holder
- BLUMONT OFTA TRADING LIMITED
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Olav Kristianslund
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Olav Kristianslund
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2022-12-02 | 2022-12-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol EU CT 2023-510091-31-00 | 1.4 |
| Recruitment arrangements (for publication) | placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Nevanac | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Spersadex | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-09 | Norway | Acceptable 2024-10-15
|
2024-10-15 |