Peripheral Avascular Retina in Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

Official title:

Long Term Management of Peripheral Avascular Retina in Retinopathy of Prematurity Evaluated by Fundus Fluorescein Angiography.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044181
• Other study ID #: Avascular Retina in ROP
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Alyaa Mohamed, MS
• Phone: 01092246445
• Email: alyaelkabsh686[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 3 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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. The laser settings used are: power 250-400 mW and duration of 200-400 ms for 810 nm DLPC.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

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):16 — View Citation

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 — View Citation

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):436-4 — View Citation

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 hi — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eyes showing peripheral retinal active leakage.	Management of active leakage by laser ablation.	18 months