Retinopathy of PrematurityPhase 1NCT05387941
Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants
A Phase 1 study testing Dexamethasone Ophthalmic in people with Retinopathy of Prematurity, run by Region Skane at 2 sites in Sweden.
Trial summary
Background and study aims When an infant is born premature, the blood vessels in the eyes have not developed fully on the retina, and can start to grow incorrectly and result in blindness. Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Dexamethasone Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesSweden
- Study dates
- 14 Jun 2022to 4 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants screened for retinopathy of prematurity (ROP) at Sahlgrenska University Hospital in Gothenburg, at Skåne University Hospital in Malmö and Lund and at Helsingborg Hospital.
- zone I stage 1 or 2 ROP without plus disease, posterior zone II stage 2 ROP without plus disease, or zone II stage 3 ROP without plus disease. ROP needs to be documented by digital widefield photography and classification confirmed by two ophthalmologist.
Who cannot join
- ocular infection
- systemic steroid treatment within two weeks before the start of drop treatment
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41685
Skåne University Hospital
Lund, Skåne County, 22185
About this study
Official title: Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants With Retinopathy of Prematurity- a Feasibility Study
Background and study aims
When an infant is born premature, the blood vessels in the eyes have not developed fully on the retina, and can start to grow incorrectly and result in blindness. To prevent this from happening, premature infants are often screened, and treated with laser or injections into the eye to prevent retinal detachment. A new treatment strategy with steroid eye drops have been found to prevent serious blood vessel growth. The treatment is commonly used in older children and adults to treat different inflammatory conditions, but how the drop is absorbed in premature infants and if there is any risk of side-effects is poorly investigated. The aim of this study is to document how the steroid drop is absorbed and excreted in premature infants and to study if there is a risk of any side effects.
Read more
Who can participate?
Premature infants born before gestational age week 30, that undergo eye-screening at Sahlgrenska University Hospital in Gothenburg and Skånes University Hospital in Malmö and Lund or at Helsingborg Hospital, in the need for steroid eye-drop treatment against pathological vessels. It is not possible to participate if the infant has received systemic steroid treatment 2 weeks prior to the eye-drop treatment, or has an ongoing ocular infection.
What does the study involve?
The study involves blood and saliva samples according to a specific protocol designed to be able to learn about the uptake and breakdown of the steroid in premature infants. Measurements of blood pressure, growth and a few urine samples will also be collected during the treatment period usually lasting for some weeks.
At 2.5 and 5 years of age, visual acuity, refractive errors and retinal thickness measurements will be noted.
What are the possible benefits and risks of participating?
The infant will receive steroid eye-drops that have been noted to heavily reduce the number of infants that develop retinal changes that require injections or laser treatment.
The blood samples have been reduced to an absolute minimum in volume and numbers, but will entail some extra samplings from the infant.
The infant will be rigorously checked with regard to any possible side effects from the steroid treatment. Possible but unlikely side effects from the low dose in eye drops are; elevated blood pressure, retarded growth, lowered endogenous steroid production during the eye-drop treatment, increase in blood glucose, and an increase in intra-ocular pressure.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Dexamethasone Ophthalmic
- Keywords
- pharmacokinetics, retinopathy of prematurity, dexamethasone
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OphthalmicDrug
Also called dexafree
one drop daily in each eye with retinopathy of prematurity of a predefined stage.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone treated infants | Experimental | 15 infants that receive dexamethasone eye drops for treatment of retinopathy of prematurity will be included, and both serum and saliva samples will be collected in order to find out the pharmacokinetic properties of dexamethasone in eye drops according to a pre-specified sampling scheme specifically designed for this purpose by experts in pediatric pharmacokinetics. Receives: Drug: Dexamethasone Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: half-life of plasma concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Half-life of dexamethasone- t½, hours
Measured: up to 14 weeks
Pharmacokinetics: maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Maximum plasma concentration- Cmax, nmol/L
Measured: up to 14 weeks
Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops.
Half-life of dexamethasone- t½, hours
Measured: up to 14 weeks
Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Maximum saliva concentration- Cmax, nmol/L
Measured: up to 14 weeks
Pharmacokinetics: time to reach maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
tmax, hours
Measured: up to 14 weeks
Pharmacokinetics: time to reach maximum saliva concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
tmax, hours
Measured: up to 14 weeks
Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.
AUC0-t, nmol.h/L
Measured: up to 14 weeks
Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.
AUC0-t, nmol.h/L
Measured: up to 14 weeks
Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to infinity;
AUC0-∞, nmol.h/L
Measured: up to 14 weeks
Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to infinity;
AUC0-∞, nmol.h/L
Measured: up to 14 weeks
Pharmacokinetics: apparent total body clearance
CL/F, L/h
Measured: up to 14 weeks
Pharmacokinetics: apparent volume of distribution
Vz/F, L
Measured: up to 14 weeks
Safety: serum concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops measured with mass spectrometry.
Endogenous levels of corticosteroids, nmol/L
Measured: up to 14 weeks
Safety: saliva concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops.
Endogenous levels of corticosteroids, nmol/L
Measured: up to 14 weeks
Secondary outcomes (8)
To describe if dexamethasone eye drops delay the intervention for type 1 ROP in cases without regression by calculating the time from detection of type 2 ROP to type 1 ROP
Time from detection of type 2 ROP to type 1 ROP, days
Measured: Up to 14 weeks
To describe if dexamethasone eye drop treatment before intervention for type 1 ROP reduces the number of recurrences after the intervention.
recurrences after laser/anti-VEGF treatment, percentage
Measured: Up to 14 weeks
To find out if retinal morphology measured with optical coherence tomography is affected by dexamethasone eye drops at 2.5 years of age.
Retinal thickness, micrometers
Measured: after 2.5 years
To find out if retinal morphology measured with optical coherence tomography is affected by dexamethasone eye drops at 5 years of age.
Retinal thickness, micrometers
Measured: after 5 years
To find out if dexamethasone eye drops affect visual acuity at 2.5 years of age
Visual acuity according to Snellen, fraction
Measured: after 2.5 years
To find out if dexamethasone eye drops affect refractive errors at 2.5 years of age
Refractive power, diopters
Measured: after 2.5 years
To find out if dexamethasone eye drops affect visual acuity at 5 years of age
Visual acuity according to Snellen, fraction
Measured: after 5 years
To find out if dexamethasone eye drops affect refractive errors at 5 years of age
refractive power, diopters
Measured: after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start14 Jun 2022
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multicenter interventional phase 1 trial
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna Maria Öhnell, PhD, Principal investigator, Ophthalmology, dep. of clinical sciences Lund, Lund University, Skåne University Hospital, SwedenAnn Hellström, prof, Principal investigator, Ophthalmology, inst. of neuroscience and physiology, University of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387941
- Sponsor's protocol ID
- 2022-00536-01
- Other IDs
- 2020-004933-19
- Status last verified
- Apr 2026
- First submitted
- 13 May 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohnell HM, Andreasson S, Granse L. Dexamethasone Eye Drops for the Treatment of Retinopathy of Prematurity. Ophthalmol Retina. 2022 Feb;6(2):181-182. doi: 10.1016/j.oret.2021.09.002. Epub 2021 Sep 10. No abstract available.
PubMed 34517147
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants With Retinopathy of Prematurity- a Feasibility Study
- ClinicalTrials.gov ID
- NCT05387941
- Acronym / sponsor ID
- 2022-00536-01
- Conditions
- Retinopathy of Prematurity
- Keywords
- pharmacokinetics, retinopathy of prematurity, dexamethasone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and study aims
When an infant is born premature, the blood vessels in the eyes have not developed fully on the retina, and can start to grow incorrectly and result in blindness. To prevent this from happening, premature infants are often screened, and treated with laser or injections into the eye to prevent retinal detachment. A new treatment strategy with steroid eye drops have been found to prevent serious blood vessel growth. The treatment is commonly used in older children and adults to treat different inflammatory conditions, but how the drop is absorbed in premature infants and if there is any risk of side-effects is poorly investigated. The aim of this study is to document how the steroid drop is absorbed and excreted in premature infants and to study if there is a risk of any side effects.
Who can participate?
Premature infants born before gestational age week 30, that undergo eye-screening at Sahlgrenska University Hospital in Gothenburg and Skånes University Hospital in Malmö and Lund or at Helsingborg Hospital, in the need for steroid eye-drop treatment against pathological vessels. It is not possible to participate if the infant has received systemic steroid treatment 2 weeks prior to the eye-drop treatment, or has an ongoing ocular infection.
What does the study involve?
The study involves blood and saliva samples according to a specific protocol designed to be able to learn about the uptake and breakdown of the steroid in premature infants. Measurements of blood pressure, growth and a few urine samples will also be collected during the treatment period usually lasting for some weeks.
At 2.5 and 5 years of age, visual acuity, refractive errors and retinal thickness measurements will be noted.
What are the possible benefits and risks of participating?
The infant will receive steroid eye-drops that have been noted to heavily reduce the number of infants that develop retinal changes that require injections or laser treatment.
The blood samples have been reduced to an absolute minimum in volume and numbers, but will entail some extra samplings from the infant.
The infant will be rigorously checked with regard to any possible side effects from the steroid treatment. Possible but unlikely side effects from the low dose in eye drops are; elevated blood pressure, retarded growth, lowered endogenous steroid production during the eye-drop treatment, increase in blood glucose, and an increase in intra-ocular pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multicenter interventional phase 1 trial
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone treated infants | Experimental | Drug: Dexamethasone Ophthalmic15 infants that receive dexamethasone eye drops for treatment of retinopathy of prematurity will be included, and both serum and saliva samples will be collected in order to find out the pharmacokinetic properties of dexamethasone in eye drops according to a pre-specified sampling scheme specifically designed for this purpose by experts in pediatric pharmacokinetics. |
Who may qualify
- Ages
- Up to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants screened for retinopathy of prematurity (ROP) at Sahlgrenska University Hospital in Gothenburg, at Skåne University Hospital in Malmö and Lund and at Helsingborg Hospital.
- zone I stage 1 or 2 ROP without plus disease, posterior zone II stage 2 ROP without plus disease, or zone II stage 3 ROP without plus disease. ROP needs to be documented by digital widefield photography and classification confirmed by two ophthalmologist.
Key exclusion criteria (2 listed)
- ocular infection
- systemic steroid treatment within two weeks before the start of drop treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone OphthalmicAlso: dexafreeone drop daily in each eye with retinopathy of prematurity of a predefined stage. | Drug | Dexamethasone treated infants |
Primary outcome
Pharmacokinetics: half-life of plasma concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Time frame: up to 14 weeks
Half-life of dexamethasone- t½, hours
Pharmacokinetics: maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Time frame: up to 14 weeks
Maximum plasma concentration- Cmax, nmol/L
Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops.
Time frame: up to 14 weeks
Half-life of dexamethasone- t½, hours
Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Time frame: up to 14 weeks
Maximum saliva concentration- Cmax, nmol/L
Pharmacokinetics: time to reach maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Time frame: up to 14 weeks
tmax, hours
Pharmacokinetics: time to reach maximum saliva concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.
Time frame: up to 14 weeks
tmax, hours
Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.
Time frame: up to 14 weeks
AUC0-t, nmol.h/L
Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.
Time frame: up to 14 weeks
AUC0-t, nmol.h/L
Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to infinity;
Time frame: up to 14 weeks
AUC0-∞, nmol.h/L
Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to infinity;
Time frame: up to 14 weeks
AUC0-∞, nmol.h/L
Pharmacokinetics: apparent total body clearance
Time frame: up to 14 weeks
CL/F, L/h
Pharmacokinetics: apparent volume of distribution
Time frame: up to 14 weeks
Vz/F, L
Safety: serum concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops measured with mass spectrometry.
Time frame: up to 14 weeks
Endogenous levels of corticosteroids, nmol/L
Safety: saliva concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops.
Time frame: up to 14 weeks
Endogenous levels of corticosteroids, nmol/L
8 secondary outcomes
To describe if dexamethasone eye drops delay the intervention for type 1 ROP in cases without regression by calculating the time from detection of type 2 ROP to type 1 ROP
Time frame: Up to 14 weeks
To describe if dexamethasone eye drop treatment before intervention for type 1 ROP reduces the number of recurrences after the intervention.
Time frame: Up to 14 weeks
To find out if retinal morphology measured with optical coherence tomography is affected by dexamethasone eye drops at 2.5 years of age.
Time frame: after 2.5 years
To find out if retinal morphology measured with optical coherence tomography is affected by dexamethasone eye drops at 5 years of age.
Time frame: after 5 years
To find out if dexamethasone eye drops affect visual acuity at 2.5 years of age
Time frame: after 2.5 years
To find out if dexamethasone eye drops affect refractive errors at 2.5 years of age
Time frame: after 2.5 years
To find out if dexamethasone eye drops affect visual acuity at 5 years of age
Time frame: after 5 years
To find out if dexamethasone eye drops affect refractive errors at 5 years of age
Time frame: after 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 34517147Ohnell HM, Andreasson S, Granse L. Dexamethasone Eye Drops for the Treatment of Retinopathy of Prematurity. Ophthalmol Retina. 2022 Feb;6(2):181-182. doi: 10.1016/j.oret.2021.09.002. Epub 2021 Sep 10. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Maria Öhnell, PhD principal investigator
Ophthalmology, dep. of clinical sciences Lund, Lund University, Skåne University Hospital, Sweden
Ann Hellström, prof principal investigator
Ophthalmology, inst. of neuroscience and physiology, University of Gothenburg, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone Ophthalmic in people with Retinopathy of Prematurity, run by Region Skane at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: half-life of plasma concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry. (time frame: up to 14 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.