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Polypoidal Choroidal VasculopathyNCT05662943

Outcomes of Tolerating Subretinal Fluid in Type 1 MNV and PCV

An observational study of Polypoidal Choroidal Vasculopathy and Choroidal Neovascularization, run by Kim's Eye Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Intravitreal aflibercept injection
Type of treatment
Injection or infusion
How many people
135 participants
Where
1 siteSouth Korea
Study dates
5 Dec 2022to 30 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jae Hui Kim

    Seoul, 150-034

Other trials in South Korea

About this study

Official title: Tolerating Subretinal Fluid in Type 1 Macular Neovascularization and Polypoidal Choroidal Vasculopathy Treated Using Aflibercept

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.

Read the detailed description

Tolerating subretinal fluid (SRF) is one of the current major issues in the field of neovascular age-related macular degeneration. Previous post-hoc analysis studies have demonstrated that SRF is not associated with poor visual acuity as well as poor visual outcome. In addition, previous studies showed that tolerating small amount of SRF may not influence visual outcome when using treat-and-extend regimen. Based on these observations, it is generally accepted that small stable amounts of SRF can be tolerated.

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.

Being tested
Intravitreal aflibercept injection
Keywords
Type 1 macular neovascularization, Polypoidal Choroidal Vasculopathy, Subretinal fluid, Aflibercept, Age-related macular degeneration
Medical subject headings
Polypoidal Choroidal Vasculopathy, Choroidal Neovascularization, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal aflibercept injectionDrug

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

Study groups in NCT05662943
Study groupRoleWhat they receive
Type 1 Macular Neovascularization and Polypoidal Choroidal VasculopathyPatients with type 1 macular neovascularization and polypoidal choroidal vasculopathy who underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months
Receives: Drug: Intravitreal aflibercept injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in visual acuity

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

    Measured: Through study completion, an average of 20 months

Secondary outcomes (12)

  1. Proportion of patients who exhibited deterioration of ≥0.3 logMAR BCVA

    Proportion of patients who exhibited deterioration of ≥0.3 logMAR BCVA between the start and the end of treatment tolerating subretinal fluid

    Measured: Through study completion, an average of 20 months

  2. Difference in the BCVA change, according to MNV subtype

    Difference in the BCVA change, according to MNV subtype (type 1 MNV vs PCV)

    Measured: Through study completion, an average of 20 months

  3. Degree of visual deterioration according to the treatment period

    Degree of visual deterioration according to the treatment period

    Measured: Through study completion, an average of 20 months

  4. Degree of visual deterioration according to the height of SRF

    Degree of visual deterioration according to the height of SRF

    Measured: Through study completion, an average of 20 months

  5. Degree of visual deterioration according to the fluctuation of SRF height

    Degree of visual deterioration according to the fluctuation of SRF height

    Measured: Through study completion, an average of 20 months

  6. Comparison of visual outcomes between the following three groups (mean SRF height <100 µm vs ≥100 µm, <200 µm vs ≥200 µm)

    Comparison of visual outcomes between the following three groups (mean SRF height <100 µm vs ≥100 µm, <200 µm vs ≥200 µm)

    Measured: Through study completion, an average of 20 months

  7. Risk factor of developing deterioration of ≥0.2 logMAR BCVA

    Risk factor of developing deterioration of ≥0.2 logMAR BCVA

    Measured: Through study completion, an average of 20 months

  8. Proportion of patients in whom the intraretinal fluid (IRF) developed during treatment tolerating SRF

    Proportion of patients in whom the IRF developed during treatment tolerating SRF

    Measured: Through study completion, an average of 20 months

  9. Difference in visual outcome between patients with and without IRF development

    Difference in visual outcome between patients with and without IRF development

    Measured: Through study completion, an average of 20 months

  10. Risk factors of IRF development

    Risk factors of IRF development

    Measured: Through study completion, an average of 20 months

  11. The incidence of vision-threatening event such as large submacular hemorrhage or tear of retinal pigment epithelium

    The incidence of vision-threatening event such as large submacular hemorrhage or tear of retinal pigment epithelium

    Measured: Through study completion, an average of 20 months

  12. The incidence of SRF resolution without shortening injection interval

    The incidence of SRF resolution without shortening injection interval

    Measured: Through study completion, an average of 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start5 Dec 2022
  3. Primary completion31 May 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05662943
Sponsor's protocol ID
2022-09-004
Status last verified
Dec 2022
First submitted
9 Dec 2022
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32980815

  • 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.

    PubMed 34393212

  • 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.

    PubMed 33782365

  • 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.

    PubMed 34839342

  • 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.

    PubMed 35033037

  • 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.

    PubMed 35119292

  • 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.

    PubMed 38489060

Questions about this trial

What is this clinical trial studying?

An observational study of Polypoidal Choroidal Vasculopathy and Choroidal Neovascularization, run by Kim's Eye Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in visual acuity (time frame: Through study completion, an average of 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05662943, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.

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