Outcomes of Tolerating Subretinal Fluid in Type 1 MNV and PCV

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662943
• Other study ID #: 2022-09-004
• Status: Completed
• Start date: December 5, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2022
• Source: Kim's Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 30, 2023
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jae Hui Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kim's Eye Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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 — View Citation

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.0 — View Citation

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 degener — View Citation

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: — View Citation

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 — View Citation

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):149-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Through study completion, an average of 20 months
Secondary	Difference in the BCVA change, according to MNV subtype	Difference in the BCVA change, according to MNV subtype (type 1 MNV vs PCV)	Through study completion, an average of 20 months
Secondary	Degree of visual deterioration according to the treatment period	Degree of visual deterioration according to the treatment period	Through study completion, an average of 20 months
Secondary	Degree of visual deterioration according to the height of SRF	Degree of visual deterioration according to the height of SRF	Through study completion, an average of 20 months
Secondary	Degree of visual deterioration according to the fluctuation of SRF height	Degree of visual deterioration according to the fluctuation of SRF height	Through study completion, an average of 20 months
Secondary	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)	Through study completion, an average of 20 months
Secondary	Risk factor of developing deterioration of =0.2 logMAR BCVA	Risk factor of developing deterioration of =0.2 logMAR BCVA	Through study completion, an average of 20 months
Secondary	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	Through study completion, an average of 20 months
Secondary	Difference in visual outcome between patients with and without IRF development	Difference in visual outcome between patients with and without IRF development	Through study completion, an average of 20 months
Secondary	Risk factors of IRF development	Risk factors of IRF development	Through study completion, an average of 20 months
Secondary	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	Through study completion, an average of 20 months
Secondary	The incidence of SRF resolution without shortening injection interval	The incidence of SRF resolution without shortening injection interval	Through study completion, an average of 20 months