NCT06044181

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 13, 2024

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

September 11, 2023

Last Update Submit

May 9, 2024

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

  • Number of eyes showing peripheral retinal active leakage.

    Management of active leakage by laser ablation.

    18 months

Study Arms (2)

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.

Procedure: Diode laser photocoagulation.

Interventions

Diode laser photocoagulation.PROCEDURE

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.

Peripheral avascular retina of ROP with active leakage.

Eligibility Criteria

Age18 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 088, Egypt

RECRUITING

Related Publications (6)

  • 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.

    PMID: 34763060RESULT

  • Hellstrom 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.

    PMID: 23782686RESULT

  • Reynolds 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.

    PMID: 12427059RESULT

  • Mansukhani 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.

    PMID: 31044736RESULT

  • Klufas 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.

    PMID: 26028345RESULT

  • Lepore 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.

    PMID: 28867130RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Alyaa Mohamed, MS

CONTACT

01092246445alyaelkabsh686@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 21, 2023

Study Start

January 1, 2024

Primary Completion

May 1, 2025

Study Completion

November 1, 2025

Last Updated

May 13, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)