Retinopathy of Prematurity (ROP)NCT07427719
Retinopathy of Prematurity - Visual Function and Retinal Structure
An observational study of Retinopathy of Prematurity (ROP) and Prematurity Complications, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Retinopathy of Prematurity (ROP), Prematurity Complications, Cerebral Visual Impairment
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2026to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: * Group 1: patients treated for ROP with laser * Group 2: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 1) * Group 3: patients treated for ROP with injection of A-VEGF * Group 4: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 3)
Who may be able to join
- Patients treated for ROP with either laser or injection of A-VEGF.
- Patients previously diagnosed with ROP but not treated for the condition.
Who cannot join
- Age below six years at date of examination.
- A developmental level not compatible with performing the study examinations.
- Patients born or treated outside Norway
- Known ocular or systemic disease that can give structural or functional changes in the retina.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Oslo University Hospital
Oslo, Oslo, 0424
Erlend C. S. Landsend, M.D., Ph.D., 0047 91 50 27 70, erllan@ous-hf.no
Amanda Schjetlein, M.D., 0047 91 50 27 70, amasch@ous-hf.no
About this study
Official title: Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common.
In this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
Read the detailed description
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). The risk of ROP increases with lower gestational age and birth weight of the child. In a child born pre-term the blood vessels in the retina may not be fully developed. New - but unstructured - vessels could grow up from the retina and lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) into the eye has become more common.
In this study, the researchers aim to explore whether treatment of ROP affects visual function and retinal development. To investigate this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
The participants will undergo a comprehensive eye examination, including imaging of the retina, visual field testing, and biometric measurements. Their parents will also answer questions regarding cerebral visual impairment.
Results from the group not treated for ROP will be compared to the treated subjects. Data will also be correlated with non-ocular parameters, such at gestational age, birth weight and brain hemorrhages.
- Conditions
- Retinopathy of Prematurity (ROP), Prematurity Complications, Cerebral Visual Impairment, Visual Field Defect
- Keywords
- Retinopathy of Prematurity, Treatment, Laser, anti-vascular endothelial growth factor, Visual field defect, Cerebral visual impairment, Refractive errors, Prematurity
- Medical subject headings
- Retinopathy of Prematurity, Blindness, Cortical, Refractive Errors, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laser treated | Subjects treated for ROP with laser of avascular retina | |
| Control laser treated | Control subjects matched with subjects treated with laser | |
| A-VEGF treated | Subjects treated for ROP with intravitreal injection of A-VEGF | |
| Control A-VEGF treated | Control subjects matched with subjects treated with A-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of the foveal avascular zone
Width of the foveal avascular zone in micrometers measured with optical coherence tomography angiography
Measured: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years
Choroidal vascularity
Choroidal vascularity in the macula measured with optical coherence tomography and with choroidal vascularity index in percent
Measured: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness in micrometers measured with optical coherence tomography
Measured: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Length of persistent avascular retina
Length of persistent avascular retina measured in millimeters using scanning laser ophthalmoscopy and fluorescein angiography
Measured: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Width of the visual field
Width of the visual field in degrees measured with Goldmann Perimetry
Measured: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Secondary outcomes (2)
Correlation between cerebral visual impairment and brain hemorrhages
Correlation between scores for cerebral visual impairment at time of the study and brain hemorrhages in neonatal period
Measured: Neonatal period to time for data collection in the current study
Visual acuity
Visual acuity measured with LogMAR.
Measured: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erlend Christoffer Sommer Landsend, Oslo University Hospital
- Investigators
- Erlend Christoffer Sommer Landsend, M.D., Ph.D., Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427719
- Sponsor's protocol ID
- 927328
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Awaits allowance to share IPD from the Regional committees for medical and health research ethics.
Publications
Hamad AE, Moinuddin O, Blair MP, Schechet SA, Shapiro MJ, Quiram PA, Mammo DA, Berrocal AM, Prakhunhungsit S, Cernichiaro-Espinosa LA, Mukai S, Yonekawa Y, Ung C, Holz ER, Harper CA 3rd, Young RC, Besirli CG, Nagiel A, Lee TC, Gupta MP, Walsh MK, Khawly JA, Campbell JP, Kychenthal A, Nudleman ED, Robinson JE, Hartnett ME, Calvo CM, Chang EY. Late-Onset Retinal Findings and Complications in Untreated Retinopathy of Prematurity. Ophthalmol Retina. 2020 Jun;4(6):602-612. doi: 10.1016/j.oret.2019.12.015. Epub 2019 Dec 24.
PubMed 32059986Lai TT, Yang CM, Hsieh YT, Yeh PT, Huang CW, Tsai CY. RATE OF AND TIME TO COMPLETE RETINAL VASCULARIZATION IN PREMATURE INFANTS AND ASSOCIATED FACTORS. Retina. 2023 Jan 1;43(1):102-110. doi: 10.1097/IAE.0000000000003627.
PubMed 36201755Sternfeld A, Rahmani S, Rossen JL, Zhang DL, Li YD, Quan VL, Huang R, Yoon HH. Long-term retinal vasculature abnormalities following intravitreal bevacizumab for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2022 Jun;260(6):1915-1921. doi: 10.1007/s00417-021-05499-0. Epub 2021 Dec 1.
PubMed 34851464Ling XC, Kang EY, Huang JL, Chou HD, Liu L, Lai CC, Chen KJ, Hwang YS, Wu WC. Persistent Vascular Anomalies in Retinopathy of Prematurity Children: Ultrawide-field Fluorescein Angiography Findings until School Age. Ophthalmol Sci. 2023 Feb 7;3(3):100281. doi: 10.1016/j.xops.2023.100281. eCollection 2023 Sep.
PubMed 37113473Edmond JC, Foroozan R. Cortical visual impairment in children. Curr Opin Ophthalmol. 2006 Dec;17(6):509-12. doi: 10.1097/ICU.0b013e3280107bc5.
PubMed 17065917Obata S, Matsumoto R, Iwasa M, Kakinoki M, Sawada O, Sawada T, Saishin Y, Ohji M. Visual field after anti-vascular endothelial growth factor therapy and laser treatment for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3207-3213. doi: 10.1007/s00417-023-06227-6. Epub 2023 Sep 6.
PubMed 37674073McLoone E, O'Keefe M, McLoone S, Lanigan B. Effect of diode laser retinal ablative therapy for threshold retinopathy of prematurity on the visual field: results of goldmann perimetry at a mean age of 11 years. J Pediatr Ophthalmol Strabismus. 2007 May-Jun;44(3):170-3. doi: 10.3928/0191-3913-20070301-10.
PubMed 17542439Cryotherapy for Retinopathy of Prematurity Cooperative Group. Effect of retinal ablative therapy for threshold retinopathy of prematurity: results of Goldmann perimetry at the age of 10 years. Arch Ophthalmol. 2001 Aug;119(8):1120-5. doi: 10.1001/archopht.119.8.1120.
PubMed 11483077Quinn GE, Dobson V, Hardy RJ, Tung B, Phelps DL, Palmer EA. Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Sep;103(9):1432-7. doi: 10.1016/s0161-6420(96)30487-9.
PubMed 8841302Ingvaldsen SH, Morken TS, Austeng D, Dammann O. Visuopathy of prematurity: is retinopathy just the tip of the iceberg? Pediatr Res. 2022 Apr;91(5):1043-1048. doi: 10.1038/s41390-021-01625-0. Epub 2021 Jun 24.
PubMed 34168272Kulmala M, Jorgensen APM, Aakvik KAD, Jussinniemi L, Benum SD, Ingvaldsen SH, Austeng D, Kajantie E, Evensen KAI, Majander A, Morken TS. Visual function in adults born preterm with very low birth weight-A two-country birth cohort study. Acta Ophthalmol. 2024 Feb;102(1):49-57. doi: 10.1111/aos.15683. Epub 2023 May 12.
PubMed 37172142Balasubramanian S, Beckmann J, Mehta H, Sadda SR, Chanwimol K, Nassisi M, Tsui I, Marlow N, Jain S. Relationship between Retinal Thickness Profiles and Visual Outcomes in Young Adults Born Extremely Preterm: The EPICure@19 Study. Ophthalmology. 2019 Jan;126(1):107-112. doi: 10.1016/j.ophtha.2018.07.030. Epub 2018 Aug 6.
PubMed 30092239Najjaran M, Zarei-Ghanavati S, Ostadimoghaddam H, Yekta A, Shoeibi N, Hemmati A, Abrishami M, Akhlaghi S, Ziaei M. Ocular Biometric and Optical Coherence Tomography Parameters in Former Preterm Children: A Cohort Study. J Ophthalmol. 2024 Sep 30;2024:2381582. doi: 10.1155/2024/2381582. eCollection 2024.
PubMed 39376685Acar DE, Acar U, Tunay ZO, Arman A, Goksuluk D. Retinal choroidal and retinal nerve fiber layer thickness in former preterm and full-term infants aged 4 to 8 years. Int Ophthalmol. 2021 Mar;41(3):1071-1079. doi: 10.1007/s10792-020-01666-0. Epub 2021 Jan 2.
PubMed 33387107Akerblom H, Holmstrom G, Eriksson U, Larsson E. Retinal nerve fibre layer thickness in school-aged prematurely-born children compared to children born at term. Br J Ophthalmol. 2012 Jul;96(7):956-60. doi: 10.1136/bjophthalmol-2011-301010. Epub 2012 May 8.
PubMed 22569283
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure
- ClinicalTrials.gov ID
- NCT07427719
- Acronym / sponsor ID
- 927328
- Conditions
- Retinopathy of Prematurity (ROP), Prematurity Complications, Cerebral Visual Impairment, Visual Field Defect
- Keywords
- Retinopathy of Prematurity, Treatment, Laser, anti-vascular endothelial growth factor, Visual field defect, Cerebral visual impairment, Refractive errors, Prematurity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 23 Feb 2026 (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.
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common.
In this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
Detailed description
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). The risk of ROP increases with lower gestational age and birth weight of the child. In a child born pre-term the blood vessels in the retina may not be fully developed. New - but unstructured - vessels could grow up from the retina and lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) into the eye has become more common.
In this study, the researchers aim to explore whether treatment of ROP affects visual function and retinal development. To investigate this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
The participants will undergo a comprehensive eye examination, including imaging of the retina, visual field testing, and biometric measurements. Their parents will also answer questions regarding cerebral visual impairment.
Results from the group not treated for ROP will be compared to the treated subjects. Data will also be correlated with non-ocular parameters, such at gestational age, birth weight and brain hemorrhages.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laser treated | – | –Subjects treated for ROP with laser of avascular retina |
| Control laser treated | – | –Control subjects matched with subjects treated with laser |
| A-VEGF treated | – | –Subjects treated for ROP with intravitreal injection of A-VEGF |
| Control A-VEGF treated | – | –Control subjects matched with subjects treated with A-VEGF |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- * Group 1: patients treated for ROP with laser * Group 2: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 1) * Group 3: patients treated for ROP with injection of A-VEGF * Group 4: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 3)
Key inclusion criteria (2 listed)
- Patients treated for ROP with either laser or injection of A-VEGF.
- Patients previously diagnosed with ROP but not treated for the condition.
Key exclusion criteria (4 listed)
- Age below six years at date of examination.
- A developmental level not compatible with performing the study examinations.
- Patients born or treated outside Norway
- Known ocular or systemic disease that can give structural or functional changes in the retina.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Width of the foveal avascular zone
Time frame: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years
Width of the foveal avascular zone in micrometers measured with optical coherence tomography angiography
Choroidal vascularity
Time frame: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Choroidal vascularity in the macula measured with optical coherence tomography and with choroidal vascularity index in percent
Retinal nerve fiber layer thickness
Time frame: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Retinal nerve fiber layer thickness in micrometers measured with optical coherence tomography
Length of persistent avascular retina
Time frame: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Length of persistent avascular retina measured in millimeters using scanning laser ophthalmoscopy and fluorescein angiography
Width of the visual field
Time frame: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Width of the visual field in degrees measured with Goldmann Perimetry
2 secondary outcomes
Correlation between cerebral visual impairment and brain hemorrhages
Time frame: Neonatal period to time for data collection in the current study
Visual acuity
Time frame: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 32059986Hamad AE, Moinuddin O, Blair MP, Schechet SA, Shapiro MJ, Quiram PA, Mammo DA, Berrocal AM, Prakhunhungsit S, Cernichiaro-Espinosa LA, Mukai S, Yonekawa Y, Ung C, Holz ER, Harper CA 3rd, Young RC, Besirli CG, Nagiel A, Lee TC, Gupta MP, Walsh MK, Khawly JA, Campbell JP, Kychenthal A, Nudleman ED, Robinson JE, Hartnett ME, Calvo CM, Chang EY. Late-Onset Retinal Findings and Complications in Untreated Retinopathy of Prematurity. Ophthalmol Retina. 2020 Jun;4(6):602-612. doi: 10.1016/j.oret.2019.12.015. Epub 2019 Dec 24.
- Background: PubMed 36201755Lai TT, Yang CM, Hsieh YT, Yeh PT, Huang CW, Tsai CY. RATE OF AND TIME TO COMPLETE RETINAL VASCULARIZATION IN PREMATURE INFANTS AND ASSOCIATED FACTORS. Retina. 2023 Jan 1;43(1):102-110. doi: 10.1097/IAE.0000000000003627.
- Background: PubMed 34851464Sternfeld A, Rahmani S, Rossen JL, Zhang DL, Li YD, Quan VL, Huang R, Yoon HH. Long-term retinal vasculature abnormalities following intravitreal bevacizumab for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2022 Jun;260(6):1915-1921. doi: 10.1007/s00417-021-05499-0. Epub 2021 Dec 1.
- Background: PubMed 37113473Ling XC, Kang EY, Huang JL, Chou HD, Liu L, Lai CC, Chen KJ, Hwang YS, Wu WC. Persistent Vascular Anomalies in Retinopathy of Prematurity Children: Ultrawide-field Fluorescein Angiography Findings until School Age. Ophthalmol Sci. 2023 Feb 7;3(3):100281. doi: 10.1016/j.xops.2023.100281. eCollection 2023 Sep.
- Background: PubMed 17065917Edmond JC, Foroozan R. Cortical visual impairment in children. Curr Opin Ophthalmol. 2006 Dec;17(6):509-12. doi: 10.1097/ICU.0b013e3280107bc5.
- Background: PubMed 37674073Obata S, Matsumoto R, Iwasa M, Kakinoki M, Sawada O, Sawada T, Saishin Y, Ohji M. Visual field after anti-vascular endothelial growth factor therapy and laser treatment for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3207-3213. doi: 10.1007/s00417-023-06227-6. Epub 2023 Sep 6.
- Background: PubMed 17542439McLoone E, O'Keefe M, McLoone S, Lanigan B. Effect of diode laser retinal ablative therapy for threshold retinopathy of prematurity on the visual field: results of goldmann perimetry at a mean age of 11 years. J Pediatr Ophthalmol Strabismus. 2007 May-Jun;44(3):170-3. doi: 10.3928/0191-3913-20070301-10.
- Background: PubMed 11483077Cryotherapy for Retinopathy of Prematurity Cooperative Group. Effect of retinal ablative therapy for threshold retinopathy of prematurity: results of Goldmann perimetry at the age of 10 years. Arch Ophthalmol. 2001 Aug;119(8):1120-5. doi: 10.1001/archopht.119.8.1120.
- Background: PubMed 8841302Quinn GE, Dobson V, Hardy RJ, Tung B, Phelps DL, Palmer EA. Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Sep;103(9):1432-7. doi: 10.1016/s0161-6420(96)30487-9.
- Background: PubMed 34168272Ingvaldsen SH, Morken TS, Austeng D, Dammann O. Visuopathy of prematurity: is retinopathy just the tip of the iceberg? Pediatr Res. 2022 Apr;91(5):1043-1048. doi: 10.1038/s41390-021-01625-0. Epub 2021 Jun 24.
- Background: PubMed 37172142Kulmala M, Jorgensen APM, Aakvik KAD, Jussinniemi L, Benum SD, Ingvaldsen SH, Austeng D, Kajantie E, Evensen KAI, Majander A, Morken TS. Visual function in adults born preterm with very low birth weight-A two-country birth cohort study. Acta Ophthalmol. 2024 Feb;102(1):49-57. doi: 10.1111/aos.15683. Epub 2023 May 12.
- Background: PubMed 30092239Balasubramanian S, Beckmann J, Mehta H, Sadda SR, Chanwimol K, Nassisi M, Tsui I, Marlow N, Jain S. Relationship between Retinal Thickness Profiles and Visual Outcomes in Young Adults Born Extremely Preterm: The EPICure@19 Study. Ophthalmology. 2019 Jan;126(1):107-112. doi: 10.1016/j.ophtha.2018.07.030. Epub 2018 Aug 6.
- Individual participant dataSharing planned: Undecided. Awaits allowance to share IPD from the Regional committees for medical and health research ethics.
Related trials for Retinopathy of Prematurity (ROP)
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
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.
Erlend Christoffer Sommer Landsend, M.D., Ph.D. study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity (ROP) and Prematurity Complications, run by Oslo University Hospital at 1 site in Norway.
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 4 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: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erlend Christoffer Sommer Landsend, M.D., Ph.D. (0047 91 50 27 70, erllan@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width of the foveal avascular zone (time frame: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years). The study lists 5 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 NCT07427719, which also lists 31 linked publications.
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 23 Feb 2026.