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Peripheral Avascular Retina in Retinopathy of Prematurity

Primary Purpose

Retinopathy of Prematurity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diode laser photocoagulation.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity

Eligibility Criteria

18 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Peripheral avascular retina of ROP with no leakage.

    Peripheral avascular retina of ROP with active leakage.

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of eyes showing peripheral retinal active leakage.
    Management of active leakage by laser ablation.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2023
    Last Updated
    September 16, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06044181
    Brief Title
    Peripheral Avascular Retina in Retinopathy of Prematurity
    Official Title
    Long Term Management of Peripheral Avascular Retina in Retinopathy of Prematurity Evaluated by Fundus Fluorescein Angiography.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinopathy of Prematurity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Peripheral avascular retina of ROP with no leakage.
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Peripheral avascular retina of ROP with active leakage.
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Diode laser photocoagulation.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of eyes showing peripheral retinal active leakage.
    Description
    Management of active leakage by laser ablation.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Months
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alyaa Mohamed, MS
    Phone
    01092246445
    Email
    alyaelkabsh686@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34763060
    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. doi: 10.1016/j.preteyeres.2021.101018. Epub 2021 Nov 9.
    Results Reference
    result
    PubMed Identifier
    23782686
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    12427059
    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 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 Reference
    result
    PubMed Identifier
    31044736
    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):436-443. doi: 10.1016/j.oret.2019.01.016. Epub 2019 Jan 31.
    Results Reference
    result
    PubMed Identifier
    26028345
    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):1601-8. doi: 10.1016/j.ophtha.2015.04.023. Epub 2015 May 28.
    Results Reference
    result
    PubMed Identifier
    28867130
    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 Findings. Ophthalmology. 2018 Feb;125(2):218-226. doi: 10.1016/j.ophtha.2017.08.005. Epub 2017 Sep 1.
    Results Reference
    result

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    Peripheral Avascular Retina in Retinopathy of Prematurity

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