Outcomes of Tolerating Subretinal Fluid in Type 1 MNV and PCV

NCT05662943 | Completed

• 1 other identifier: 2022-09-004
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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 subretinal fluid (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 polypoidal choroidal vasculopathy (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.

Conditions

Polypoidal Choroidal Vasculopathy; Choroidal Neovascularization; Age-Related Macular Degeneration

Keywords

Type 1 macular neovascularization; Polypoidal Choroidal Vasculopathy; Subretinal fluid; Aflibercept; Age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• Changes in visual acuity

  Change in best-corrected visual acuity (BCVA) between the start and the end of treatment tolerating subretinal fluid

  Through study completion, an average of 20 months

Secondary Outcomes (12)

• Proportion of patients who exhibited deterioration of ≥0.3 logMAR BCVA

  Through study completion, an average of 20 months

• Difference in the BCVA change, according to MNV subtype

  Through study completion, an average of 20 months

• Degree of visual deterioration according to the treatment period

  Through study completion, an average of 20 months

• Degree of visual deterioration according to the height of SRF

  Through study completion, an average of 20 months

• Degree of visual deterioration according to the fluctuation of SRF height

  Through study completion, an average of 20 months

Study Arms (1)

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

Drug: Intravitreal aflibercept injection

Interventions

Intravitreal aflibercept injection DRUG

Intravitreal injection of aflibercept (0.2 mg / 0,05 ml; Bayer Co. Ltd.,)

Type 1 Macular Neovascularization and Polypoidal Choroidal Vasculopathy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were diagnosed with type 3 MNV or PCV and underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months

You may qualify if:

• Patient who were diagnosed with type 1 MNV or PCV
• 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.

You may not qualify if:

• Less than 6 months of tolerating-fluid phase
• 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)

Sponsors & Collaborators

• Kim's Eye Hospital: lead

Study Sites (1)

Jae Hui Kim

Seoul, 150-034, South Korea

Location

Related Publications (7)

• 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.

  PMID: 32980815 RESULT

• 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.

  PMID: 34393212 RESULT

• 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.

  PMID: 33782365 RESULT

• 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.

  PMID: 34839342 RESULT

• 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.

  PMID: 35033037 RESULT

• 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.

  PMID: 35119292 RESULT

• 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.

  PMID: 38489060 DERIVED

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy; Choroidal Neovascularization; Macular Degeneration

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Study Officials

• Jae Hui Kim, M.D.

  Kim's Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 23, 2022
• Study Start: December 5, 2022
• Primary Completion: May 31, 2023
• Study Completion: November 30, 2023
• Last Updated: December 14, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)