Retinopathy of PrematurityNCT06044181
Peripheral Avascular Retina in Retinopathy of Prematurity
A study testing Diode laser photocoagulation. in people with Retinopathy of Prematurity, run by Assiut University at 1 site in Egypt.
Trial summary
Retinopathy of prematurity (ROP) is a widely known retinal vascular disorder in preterm infants and a leading cause of visual disability or blindness in children. Advances in antenatal care have resulted in an increase in the survival rate of infants with extremely low birth weight (BW). Read more about this study
- Who is it for?
- Ages 18 months to 3 years
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Diode laser photocoagulation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Nov 2025
- Phase
- Interventional
- 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 18 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with persistent peripheral avascular retina attending follow up till the age of 18 months in the core study whether;
- regressed ROP: children with regressed ROP who had not received any treatment.
- IVI treatment ROP: children with a history of threshold ROP treated with IVI of anti-VEGF agents.
Who cannot join
- Eyes with previous laser therapy.
- Eyes with any other pathology, other than ROP.
- Eyes with stage 4 or 5 ROP.
- Patients with hypersensitivity to iodinated contrast media, liver and renal insufficiency, history of asthma.
- Patients who will show hypersensitivity reaction to fluorescein angiography will be excluded from the thesis.
- Patients unfit for general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Management of Peripheral Avascular Retina in Retinopathy of Prematurity Evaluated by Fundus Fluorescein Angiography.
Retinopathy of prematurity (ROP) is a widely known retinal vascular disorder in preterm infants and a leading cause of visual disability or blindness in children. Advances in antenatal care have resulted in an increase in the survival rate of infants with extremely low birth weight (BW). Approximately 90% of infants who develop ROP do so by a postmenstrual age of 46.3 weeks. In certain patients with or without treatment, the retina may fail to fully vascularize or may develop vascular abnormalities, thus demonstrating persistent avascular retina (PAR) or anomalous vessel findings at the periphery. Because of the advent of technologies such as ultrawide-field fluorescein angiography (UWFFA) persistent vascular abnormalities can be detected more readily and investigated.
Read the detailed description
The natural history of peripheral nonperfusion and vascular abnormalities, which persist beyond the acute phase of ROP, remains poorly understood. Although patients with a history of type I ROP (treatment requiring ROP) are more likely to exhibit abnormal foveal development and poor vision, a discrepancy still exists between the structural and functional findings of vascular abnormalities in the long term. For instance, circumferential atypical vessels are detected in patients with spontaneously regressed ROP and favorable vision. Additionally, persistent retinal vascular abnormalities may not necessarily predict adverse functional outcomes. The significance of such vessel anomalies and whether they persist or not remain uncertain. The physiologic avascular retina of children of age < 13 years usually extends ≤ 1.5 DD temporally or ≤ 1.0 DD nasally from the ora serrata. Therefore, the PAR (peripheral avascular retina) is defined as the nonperfusion area with measurements ≥ 2.0 DD, which is 3 standard deviations more than the normal value. Infants with persistent avascular retina have unknown long-term structural and functional risks, and theoretically could develop disease requiring treatment, including retinal breaks or tractional bands. Prolonged retinal traction by remnant shunt or extra-retinal fibrovascular proliferation between a stable prenatally vascularized retina in the posterior pole and an unstable postnatally vascularized retina may lead to the development of retinal holes characteristically located in the fragile, anterior undifferentiated avascular retina. Treatment options may vary from observation to retinal laser photocoagulation.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Diode laser photocoagulation.
- 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.
Diode laser photocoagulation.Procedure or surgery
If there is evidence of active leakage by FFA The confluent laser burns will be applied to the entire avascular retina from the ridge to the ora serrata for 360 through the transpupillary route. The laser settings used are: power 250-400 mW and duration of 200-400 ms for 810 nm DLPC.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral avascular retina of ROP with no leakage. | No intervention | If there is no active leakage detected by FFA, patients would be observed. The follow-up period: FFA will be done at the age of 18 months we will repeat FFA every 6 months and fundus examination with color photography every 3 months till the age of 3 years of children. |
| Peripheral avascular retina of ROP with active leakage. | Active comparator | If there is evidence of active leakage by FFA The confluent laser burns will be applied to the entire avascular retina from the ridge to the ora serrata for 360 through the transpupillary route. Receives: Procedure: Diode laser photocoagulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eyes showing peripheral retinal active leakage.
Management of active leakage by laser ablation.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 Assiut UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyaa mohamed yousef ahmed elkabsh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044181
- Sponsor's protocol ID
- Avascular Retina in ROP
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsai AS, Chou HD, Ling XC, Al-Khaled T, Valikodath N, Cole E, Yap VL, Chiang MF, Chan RVP, Wu WC. Assessment and management of retinopathy of prematurity in the era of anti-vascular endothelial growth factor (VEGF). Prog Retin Eye Res. 2022 May;88:101018. doi: 10.1016/j.preteyeres.2021.101018. Epub 2021 Nov 9.
PubMed 34763060Hellstrom A, Smith LE, Dammann O. Retinopathy of prematurity. Lancet. 2013 Oct 26;382(9902):1445-57. doi: 10.1016/S0140-6736(13)60178-6. Epub 2013 Jun 17.
PubMed 23782686Reynolds JD, Dobson V, Quinn GE, Fielder AR, Palmer EA, Saunders RA, Hardy RJ, Phelps DL, Baker JD, Trese MT, Schaffer D, Tung B; CRYO-ROP and LIGHT-ROP Cooperative Study Groups. Evidence-based screening criteria for retinopathy of prematurity: natural history data from the CRYO-ROP and LIGHT-ROP studies. Arch Ophthalmol. 2002 Nov;120(11):1470-6. doi: 10.1001/archopht.120.11.1470.
PubMed 12427059Mansukhani SA, Hutchinson AK, Neustein R, Schertzer J, Allen JC, Hubbard GB. Fluorescein Angiography in Retinopathy of Prematurity: Comparison of Infants Treated with Bevacizumab to Those with Spontaneous Regression. Ophthalmol Retina. 2019 May;3(5):436-443. doi: 10.1016/j.oret.2019.01.016. Epub 2019 Jan 31.
PubMed 31044736Klufas MA, Patel SN, Ryan MC, Patel Gupta M, Jonas KE, Ostmo S, Martinez-Castellanos MA, Berrocal AM, Chiang MF, Chan RV. Influence of Fluorescein Angiography on the Diagnosis and Management of Retinopathy of Prematurity. Ophthalmology. 2015 Aug;122(8):1601-8. doi: 10.1016/j.ophtha.2015.04.023. Epub 2015 May 28.
PubMed 26028345Lepore D, Quinn GE, Molle F, Orazi L, Baldascino A, Ji MH, Sammartino M, Sbaraglia F, Ricci D, Mercuri E. Follow-up to Age 4 Years of Treatment of Type 1 Retinopathy of Prematurity Intravitreal Bevacizumab Injection versus Laser: Fluorescein Angiographic Findings. Ophthalmology. 2018 Feb;125(2):218-226. doi: 10.1016/j.ophtha.2017.08.005. Epub 2017 Sep 1.
PubMed 28867130
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Management of Peripheral Avascular Retina in Retinopathy of Prematurity Evaluated by Fundus Fluorescein Angiography.
- ClinicalTrials.gov ID
- NCT06044181
- Acronym / sponsor ID
- Avascular Retina in ROP
- Conditions
- Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
Retinopathy of prematurity (ROP) is a widely known retinal vascular disorder in preterm infants and a leading cause of visual disability or blindness in children. Advances in antenatal care have resulted in an increase in the survival rate of infants with extremely low birth weight (BW). Approximately 90% of infants who develop ROP do so by a postmenstrual age of 46.3 weeks. In certain patients with or without treatment, the retina may fail to fully vascularize or may develop vascular abnormalities, thus demonstrating persistent avascular retina (PAR) or anomalous vessel findings at the periphery. Because of the advent of technologies such as ultrawide-field fluorescein angiography (UWFFA) persistent vascular abnormalities can be detected more readily and investigated.
Detailed description
The natural history of peripheral nonperfusion and vascular abnormalities, which persist beyond the acute phase of ROP, remains poorly understood. Although patients with a history of type I ROP (treatment requiring ROP) are more likely to exhibit abnormal foveal development and poor vision, a discrepancy still exists between the structural and functional findings of vascular abnormalities in the long term. For instance, circumferential atypical vessels are detected in patients with spontaneously regressed ROP and favorable vision. Additionally, persistent retinal vascular abnormalities may not necessarily predict adverse functional outcomes. The significance of such vessel anomalies and whether they persist or not remain uncertain. The physiologic avascular retina of children of age < 13 years usually extends ≤ 1.5 DD temporally or ≤ 1.0 DD nasally from the ora serrata. Therefore, the PAR (peripheral avascular retina) is defined as the nonperfusion area with measurements ≥ 2.0 DD, which is 3 standard deviations more than the normal value. Infants with persistent avascular retina have unknown long-term structural and functional risks, and theoretically could develop disease requiring treatment, including retinal breaks or tractional bands. Prolonged retinal traction by remnant shunt or extra-retinal fibrovascular proliferation between a stable prenatally vascularized retina in the posterior pole and an unstable postnatally vascularized retina may lead to the development of retinal holes characteristically located in the fragile, anterior undifferentiated avascular retina. Treatment options may vary from observation to retinal laser photocoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral avascular retina of ROP with no leakage. | No intervention | –If there is no active leakage detected by FFA, patients would be observed. The follow-up period: FFA will be done at the age of 18 months we will repeat FFA every 6 months and fundus examination with color photography every 3 months till the age of 3 years of children. |
| Peripheral avascular retina of ROP with active leakage. | Active comparator | Procedure: Diode laser photocoagulation.If there is evidence of active leakage by FFA The confluent laser burns will be applied to the entire avascular retina from the ridge to the ora serrata for 360 through the transpupillary route. |
Who may qualify
- Ages
- 18 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with persistent peripheral avascular retina attending follow up till the age of 18 months in the core study whether;
- regressed ROP: children with regressed ROP who had not received any treatment.
- IVI treatment ROP: children with a history of threshold ROP treated with IVI of anti-VEGF agents.
Key exclusion criteria (6 listed)
- Eyes with previous laser therapy.
- Eyes with any other pathology, other than ROP.
- Eyes with stage 4 or 5 ROP.
- Patients with hypersensitivity to iodinated contrast media, liver and renal insufficiency, history of asthma.
- Patients who will show hypersensitivity reaction to fluorescein angiography will be excluded from the thesis.
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 |
|---|---|---|
| Diode laser photocoagulation.If there is evidence of active leakage by FFA The confluent laser burns will be applied to the entire avascular retina from the ridge to the ora serrata for 360 through the transpupillary route. The laser settings used are: power 250-400 mW and duration of 200-400 ms for 810 nm DLPC. | Procedure or surgery | Peripheral avascular retina of ROP with active leakage. |
Primary outcome
Number of eyes showing peripheral retinal active leakage.
Time frame: 18 months
Management of active leakage by laser ablation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 34763060Tsai AS, Chou HD, Ling XC, Al-Khaled T, Valikodath N, Cole E, Yap VL, Chiang MF, Chan RVP, Wu WC. Assessment and management of retinopathy of prematurity in the era of anti-vascular endothelial growth factor (VEGF). Prog Retin Eye Res. 2022 May;88:101018. doi: 10.1016/j.preteyeres.2021.101018. Epub 2021 Nov 9.
- Results publication: PubMed 23782686Hellstrom A, Smith LE, Dammann O. Retinopathy of prematurity. Lancet. 2013 Oct 26;382(9902):1445-57. doi: 10.1016/S0140-6736(13)60178-6. Epub 2013 Jun 17.
- Results publication: PubMed 12427059Reynolds JD, Dobson V, Quinn GE, Fielder AR, Palmer EA, Saunders RA, Hardy RJ, Phelps DL, Baker JD, Trese MT, Schaffer D, Tung B; CRYO-ROP and LIGHT-ROP Cooperative Study Groups. Evidence-based screening criteria for retinopathy of prematurity: natural history data from the CRYO-ROP and LIGHT-ROP studies. Arch Ophthalmol. 2002 Nov;120(11):1470-6. doi: 10.1001/archopht.120.11.1470.
- Results publication: PubMed 31044736Mansukhani SA, Hutchinson AK, Neustein R, Schertzer J, Allen JC, Hubbard GB. Fluorescein Angiography in Retinopathy of Prematurity: Comparison of Infants Treated with Bevacizumab to Those with Spontaneous Regression. Ophthalmol Retina. 2019 May;3(5):436-443. doi: 10.1016/j.oret.2019.01.016. Epub 2019 Jan 31.
- Results publication: PubMed 26028345Klufas MA, Patel SN, Ryan MC, Patel Gupta M, Jonas KE, Ostmo S, Martinez-Castellanos MA, Berrocal AM, Chiang MF, Chan RV. Influence of Fluorescein Angiography on the Diagnosis and Management of Retinopathy of Prematurity. Ophthalmology. 2015 Aug;122(8):1601-8. doi: 10.1016/j.ophtha.2015.04.023. Epub 2015 May 28.
- Results publication: PubMed 28867130Lepore D, Quinn GE, Molle F, Orazi L, Baldascino A, Ji MH, Sammartino M, Sbaraglia F, Ricci D, Mercuri E. Follow-up to Age 4 Years of Treatment of Type 1 Retinopathy of Prematurity Intravitreal Bevacizumab Injection versus Laser: Fluorescein Angiographic Findings. Ophthalmology. 2018 Feb;125(2):218-226. doi: 10.1016/j.ophtha.2017.08.005. Epub 2017 Sep 1.
- Individual participant dataSharing planned: No
Related trials for Retinopathy of Prematurity
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
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser photocoagulation. in people with Retinopathy of Prematurity, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 May 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alyaa Mohamed, MS (01092246445, alyaelkabsh686@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eyes showing peripheral retinal active leakage. (time frame: 18 months). 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 NCT06044181, which also lists 6 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 13 May 2024.