Outcomes of Tolerating Subretinal Fluid in Type 1 MNV and PCV
NCT ID: NCT05662943
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
135 participants
OBSERVATIONAL
2022-12-05
2023-11-30
Brief Summary
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Detailed Description
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To date, several clinical trials evaluated association of residual SRF with visual outcome. In these clinical trials, treatment was performed based on strict study protocol. In addition, strict rescue treatment criteria impeded definite under-treatment. However, in a clinical setting, non-scientific factors such as financial or time burden, fear to injection and compliance can influence treatment decisions. As a result, in some patients, more intensive treatment cannot be performed despite substantial amount of persistent retinal fluid.
Unlike clinical trials, in real-world practice it is difficult to precisely measure and tolerate fluid in strict amounts. As a result, large degree of fluctuation of fluid volume can occur in some patients. In addition, large amounts of fluid, which may not be tolerated in clinical trials, can persist for a relatively long period. Such cases are usually difficult to encounter in clinical trials because these patients are either treated more intensively or are dropped from the trial. Investigating the outcomes in these cases can provide useful information that cannot be obtained from clinical trials.
The purpose of the present study was to evaluate the outcomes of type 1 macular neovascularization (MNV), including polypoidal choroidal vasculopathy in patients treated tolerating SRF using Aflibercept in a clinical setting. Approximately 150 patients are anticipated to be enrolled in this study. SRF is a primary type of fluid compartment prevalent in type 1 aneurysmal MNV. In a recent study, the prevalence of SRF during 24-month follow-up period was 36.7% to 38.8% in type 1 MNV and PCV, 20.0% in type 2 MNV, and 7.7% in type 3 MNV. In addition, patients with SRF showed better visual prognosis in type 1 MNV/PCV. For this reason, type 1 MNV is an appropriate candidate for evaluating the influence of tolerating SRF.
This study may contribute to the better understanding the influence of tolerating SRF on treatment outcomes in patients diagnosed with this subtype of neovascular age-related macular degeneration (AMD). In addition, it may also contribute to the evolution of aflibercept T\&E therapy, and provide evidence for physicians to guide treatment decisions.
Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Type 1 Macular Neovascularization and Polypoidal Choroidal Vasculopathy
Patients with type 1 macular neovascularization and polypoidal choroidal vasculopathy who underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months
Intravitreal aflibercept injection
Intravitreal injection of aflibercept (0.2 mg / 0,05 ml; Bayer Co. Ltd.,)
Interventions
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Intravitreal aflibercept injection
Intravitreal injection of aflibercept (0.2 mg / 0,05 ml; Bayer Co. Ltd.,)
Eligibility Criteria
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Inclusion Criteria
* Patients who were treated using aflibercept between January 2021 and December 2022
* Patients underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months.
Exclusion Criteria
* Patients without indocyanine green angiography (ICGA) result
* Patients who received other treatment for neovascular age-related macular degeneration (AMD), except for aflibercept (eg. ranibizumab, bevacizumab, or PDT)
* History of intraocular or periocular steroid injection
* History of vitreoretinal surgery or glaucoma surgery
* History of intraocular inflammation
* Uncontrolled glaucoma (IOP ≥ 25mmHg)
50 Years
ALL
No
Sponsors
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Kim's Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Jae Hui Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kim's Eye Hospital
Locations
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Jae Hui Kim
Seoul, , South Korea
Countries
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References
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Sharma A, Parachuri N, Kumar N, Bandello F, Kuppermann BD, Loewenstein A, Regillo CD, Chakravarthy U. Notion of tolerating subretinal fluid in neovascular AMD: understanding the fine print before the injection pause. Br J Ophthalmol. 2021 Feb;105(2):149-150. doi: 10.1136/bjophthalmol-2020-317933. Epub 2020 Sep 26. No abstract available.
Chaudhary V, Matonti F, Zarranz-Ventura J, Stewart MW. IMPACT OF FLUID COMPARTMENTS ON FUNCTIONAL OUTCOMES FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Systematic Literature Review. Retina. 2022 Apr 1;42(4):589-606. doi: 10.1097/IAE.0000000000003283.
Mitchell P, Holz FG, Hykin P, Midena E, Souied E, Allmeier H, Lambrou G, Schmelter T, Wolf S; ARIES study investigators. EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT USING A TREAT-AND-EXTEND REGIMEN FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The ARIES Study: A Randomized Clinical Trial. Retina. 2021 Sep 1;41(9):1911-1920. doi: 10.1097/IAE.0000000000003128.
Chaikitmongkol V, Sagong M, Lai TYY, Tan GSW, Ngah NF, Ohji M, Mitchell P, Yang CH, Ruamviboonsuk P, Wong I, Sakamoto T, Rajendran A, Chen Y, Lam DSC, Lai CC, Wong TY, Cheung CMG, Chang A, Koh A. Treat-and-Extend Regimens for the Management of Neovascular Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy: Consensus and Recommendations From the Asia-Pacific Vitreo-retina Society. Asia Pac J Ophthalmol (Phila). 2021 Nov 24;10(6):507-518. doi: 10.1097/APO.0000000000000445.
Cheng CK, Chen SJ, Chen JT, Chen LJ, Chen SN, Chen WL, Hsu SM, Lai CH, Sheu SJ, Wu PC, Wu WC, Wu WC, Yang CM, Yeung L, Chen TC, Yang CH. Optimal approaches and criteria to treat-and-extend regimen implementation for Neovascular age-related macular degeneration: experts consensus in Taiwan. BMC Ophthalmol. 2022 Jan 15;22(1):25. doi: 10.1186/s12886-021-02231-8.
Kim JH, Kim JW, Kim CG. Difference Between the Incidence of Retinal Fluid Subtypes and Their Association with Visual Outcomes According to the Types of Macular Neovascularization in a Korean Population. J Ocul Pharmacol Ther. 2022 Apr;38(3):261-268. doi: 10.1089/jop.2021.0103. Epub 2022 Feb 3.
Lee JH, Kim JH. Impact of Prolonged Persisting Subretinal Fluid on the Outcome of Aflibercept Treatment in Neovascular Age-Related Macular Degeneration. J Ocul Pharmacol Ther. 2024 Mar;40(2):136-143. doi: 10.1089/jop.2023.0124. Epub 2024 Jan 12.
Other Identifiers
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2022-09-004
Identifier Type: -
Identifier Source: org_study_id