A Phase 4 interventional study of Aflibercept Injection in Retinal Angiomatous Proliferation, sponsored by Kim's Eye Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Kim's Eye Hospital · Phase 4, Interventional, and Treatment
Type 3 neovascularization is a subtype of neovascular age-related macular degeneration (AMD) that is characterized by intraretinal neovascularization. Treat-and-extend (TAE) regimen is a widely-used, effective anti-vascular endothelial growth factor treatment regimen for neovascular AMD, regardless of subtypes of AMD. The purpose of the present study is to investigate the 18-month treatment outcome of TAE in type 3 neovascularization.
Type 3 neovascularization also called retinal angiomatous proliferation is a subtype of neovascular age-related macular degeneration (AMD) that is characterized by intraretinal neovascularization.
The incidence of type 3 neovascularization is relatively lower than other subtypes of neovascular AMD, constituting 10 to 20% of entire neovascular AMD. However, it is a very important disorder because it often leads bilateral visual deterioration. The high risk of bilateral involvement is characteristic of type 3 neovascularization. In some cases, the visual prognosis of the initially uninvolved eye with better vision, is poorer than the initially involved eye. In addition, profound visual loss may occur during the treatment course, especially in undertreated cases. Thus, preserving vision is particularly important in type 3 neovascularization, which subsequently highlights the importance of investigating more effective treatment strategies. Previous study suggested the need for proactive treatment in type 3 neovascularization to reduce the risk of abrupt visual loss.
Treat-and-extend (TAE) regimen is a widely-used, effective anti-vascular endothelial growth factor treatment regimen for neovascular age-related macular degeneration (AMD), regardless of subtypes of AMD. However, since type 3 neovascularization is at high risk of GA, there has been some debate regarding the benefit of TAE, when compared to the as-needed regimen, for treating type 3 neovascularization. Despite some controversy, reports indicated that increased injection frequency is associated with development or progression of GA. Thus, it is important to balance efficacy and efficiency when treating type 3 neovascularization.
Type 3 neovascularization is a disorder in which the treatment outcome of TAE regimen was first reported. Nevertheless, only limited evidence has been available regarding the efficacy of TAE using aflibercept in this disorder. In addition, all the previous studies were retrospective, based on relatively small study population. Moreover, results of extending the injection interval to 4 months have not yet been reported. Recently, ALTAIR study provides a scientific evidence that injection interval can be extended to 4 months when using TAE regimen. In type 3 neovascularization, extending the injection interval is not only decreases treatment burden of the patient, but also may improve long-term visual outcomes because it may decrease the injection frequency. If this regimen is found to be effective in type 3 neovascularization, it may contribute to more widespread use of TAE regimen using aflibercept for type 3 neovascularization.
In addition, there are two questions which have not been addressed in previous TAE studies for type 3 neovascularization. The first question is "Is the treatment using TAE regimen can impede the fundamental progression of the disorder?". Since visual loss in type 3 neovascularization usually develops in stage 3 disorder (eyes exhibits serous pigment epithelial detachment on OCT, it will be a very meaningful result if TAE can impede stage progression. The second question is "Is there any clues to predict the recurrence of fluid?" Since avoiding under-treatment is very important in type 3 neovascularization, it is very important to identify any factor predictive of recurrence. To address this question, it is necessary to evaluate the serial changes in vascular morphology of type 3 neovascularization lesion. Previously, however, this kind of approach cannot be performed because it requires frequent, serial indocyanine-green angiography examination. Fortunately, recent advent of OCT-angiography provides simple and safe evaluation of vascular morphology. By using OCT-angiography, any vascular morphologic changes preceding the recurrence of fluid during the TAE treatment can be evaluated.
The purpose of the present study is to investigate the 18-month treatment outcome of TAE in type 3 neovascularization. The maximum injection interval was set as 4 months. Since the ALTAIR study nicely show how to extend the interval to 4 months, the study protocol of ALTAIR study was partly adopted in the present study.
Kim's Eye Hospital is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated with aflibercept (2.0ml/0.05cc) using treat-and-extend regimen. Three monthly loading injections followed by proactive treatment using treat-and-extend regimen. Extension of injection interval by 2 weeks. The maximum injection interval was set as 16 weeks.
Drug: Aflibercept Injection
Intravitreal injection of aflibercept using treat-and-extend regimen :Three monthly loading injections followed by proactive treatment using TAE regimen. Extension of injection interval by 2 weeks. The maximum injection interval was set as 16 weeks.
Also known as: Intravitreal injection of aflibercept (Eylea, Bayer co.)
Change in best-corrected visual acuity (BCVA)
Change in early treatment of diabetic retinopathy score (ETDRS) BCVA from baseline to week 76
Time frame: From baseline to week 76
Proportion of patients who gain ≥15 ETDRS letters
Measuring proportion of patients who gain ≥15 ETDRS letters
Time frame: from baseline to week 52 and 76
Proportion of patients who loss ≥15 ETDRS letters
Measuring proportion of patients who loss ≥15 ETDRS letters
Time frame: from baseline to week 52 and 76
Change in BCVA to wee 52 (interim analysis)
Change in ETDRS BCVA
Time frame: from baseline to week 52
Change in central retinal thickness
Change in central retinal thickness measured using optical coherence tomography
Time frame: from baseline to week 52 and 76
Proportion of patients without fluid or hemorrhage
The presence of fluid or hemorrhage is estimated using fundus photographs and optical coherence tomography images
Time frame: at week 52 and 76
Incidence of geographic atrophy
Geographic atrophy is idenfitied using fundus photographs and optical coherence tomography images
Time frame: at baseline, and at weeks 52 and 76
Changes in size of geographic atrophy
Changes in size of geographic atrophy is estimated using fundus photographs and optical coherence tomography images
Time frame: from baseline to week 52 and 76
Number of injections
Number of injections were counted
Time frame: up to week 52 and 76
The maximum treatment interval and the maximum next planned interval
The maximum treatment interval and the maximum next planned interval of assessment at the last injection
Time frame: during week 52 and 76
Proportion of patients showing fovea-involving geographic atrophy or fibrotic scar
Fovea-involving geographic atrophy or fibrotic scar are idenfitied using fundus photographs and optical coherence tomography images
Time frame: at week 52 and 76
Proportion of patients showing progression of stages of type 3 neovascularization
Progress of disese stages are estimated using optical coherence tomography angiography images
Time frame: Through study completion, 72 weeks
Proportion of patients showing tear of retinal pigment epithelium or subretinal hemorrhage
Tear of retinal pigment epithelium or subretinal hemorrhage are idenfitied using fundus photographs and optical coherence tomography images
Time frame: Through study completion, 72 weeks
Morphologic features of type 3 lesion
Morphologic features of type 3 lesions are estimated using optical coherence tomography angiography images
Time frame: Through study completion, 72 weeks
Plan to share: No
Started Feb 2021 (actual). Primary completion is estimated for Dec 2023, 34 months after the start.
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Studies of the drug tested here: Aflibercept
Kim's Eye Hospital