An observational study in Polypoidal Choroidal Vasculopathy, Choroidal Neovascularization and Age-Related Macular Degeneration, sponsored by Kim's Eye Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Kim's Eye Hospital · Observational
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.
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.
54 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 6 are open to participants now.
This study's enrollment of 135 is close to the median of 135 across 13 observational studies indexed under Polypoidal Choroidal Vasculopathy.
Browse Polypoidal Choroidal Vasculopathy studies →Kim's Eye Hospital is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients were diagnosed with type 3 MNV or PCV and underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Intravitreal injection of aflibercept (0.2 mg / 0,05 ml; Bayer Co. Ltd.,)
Changes in visual acuity
Change in best-corrected visual acuity (BCVA) between the start and the end of treatment tolerating subretinal fluid
Time frame: Through study completion, an average of 20 months
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
Time frame: Through study completion, an average of 20 months
Difference in the BCVA change, according to MNV subtype
Difference in the BCVA change, according to MNV subtype (type 1 MNV vs PCV)
Time frame: Through study completion, an average of 20 months
Degree of visual deterioration according to the treatment period
Degree of visual deterioration according to the treatment period
Time frame: Through study completion, an average of 20 months
Degree of visual deterioration according to the height of SRF
Degree of visual deterioration according to the height of SRF
Time frame: Through study completion, an average of 20 months
Degree of visual deterioration according to the fluctuation of SRF height
Degree of visual deterioration according to the fluctuation of SRF height
Time frame: Through study completion, an average of 20 months
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)
Time frame: Through study completion, an average of 20 months
Risk factor of developing deterioration of ≥0.2 logMAR BCVA
Risk factor of developing deterioration of ≥0.2 logMAR BCVA
Time frame: Through study completion, an average of 20 months
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
Time frame: Through study completion, an average of 20 months
Difference in visual outcome between patients with and without IRF development
Difference in visual outcome between patients with and without IRF development
Time frame: Through study completion, an average of 20 months
Risk factors of IRF development
Risk factors of IRF development
Time frame: Through study completion, an average of 20 months
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
Time frame: Through study completion, an average of 20 months
The incidence of SRF resolution without shortening injection interval
The incidence of SRF resolution without shortening injection interval
Time frame: Through study completion, an average of 20 months
Plan to share: No
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