Efficacy of dual 8 mg aflibercept loading doses in treatment-naive patients with neovascular age-related macular degeneration

Trial ID: 2025-523478-17-00
Sponsor: Medical University Of Graz

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Diseases & Conditions

Neovascular age-related macular degeneration

Objectives

The primary objective is to evaluate the efficacy of two initial 8 mg loading doses of aflibercept in achieving non-active disease in treatment-naive patients with neovascular age-related macular degeneration. Secondary objectives include the identification of characteristics predictive of disease activity, as well as the assessment of the impact of the initial loading doses on the time of recurrence and functional development.

Participants

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with neovascular age-related macular degeneration. The participants include both males and females within the specified age ranges. Eligible individuals must be treatment-naïve in the study eye and present with type 1 or type 2 disease. The diagnosis requires confirmation via fluorescein angiography or indocyanine green angiography. Inclusion requires a choroidal neovascularization lesion size of nine or fewer disc areas. Additionally, the best-corrected visual acuity must be between 24 and 78 ETDRS letters on day 1. One eye is designated as the study eye, specifically the one exhibiting lower visual acuity if both eyes meet the eligibility requirements.

Plans and Procedures

This study is a phase 3 clinical trial designed to evaluate the efficacy of two initial loading doses of aflibercept 8 mg in patients with treatment-naïve neovascular age-related macular degeneration. The primary objective is to determine the proportion of patients achieving a non-active disease state at week 8. The research methodology involves an initial screening visit to confirm eligibility based on specific criteria, including age, diagnosis via fluorescein angiography or indocyanine green angiography, and a baseline best corrected visual acuity between 78 and 24 ETDRS letters. Following screening, participants will receive intravitreal injections of the study product. Subsequent follow-up assessments will occur at 4 and 8 weeks to monitor changes in central subfield thickness, macular fluid volume, and visual acuity. Secondary endpoints include the evaluation of treatment intervals between the second and third injections, as well as the predictive value of optical coherence tomography and optical coherence tomography angiography measurements. The study aims to assess the transition to a non-active disease state through these scheduled clinical evaluations.

Treatment

The experimental treatment consists of aflibercept, provided as an Eylea 114.3 mg/ml solution for injection. The administration involves two loading doses of 8 mg via intravitreal injection.

Efficacy

The primary efficacy endpoint is the proportion of patients without disease activity at week 8. The study evaluates the effectiveness of two 8 mg aflibercept loading doses in achieving a non-active disease state in patients with neovascular age-related macular degeneration.

Secondary efficacy parameters include:

The proportion of patients with a treatment interval of 4, 6, 8, 10, 12, 14, or 16 weeks between the second loading dose and the third aflibercept 8 mg injection.
Changes in best corrected visual acuity from baseline to week 4 and week 8.
Changes in central subfield thickness and macular fluid volume from baseline to week 4 and week 8.
Measurements obtained through optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), and angiography to identify characteristics that predict active or non-active disease.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Patients must be ≥50 years old on day 1.
All patients must be nAMD (neovascular age-related macular degeneration) treatment-naïve on the study eye.
All AMDs must be type 1 or 2.
Choroidal neovascularization lesion size have to be of nine or fewer disc areas.
For each participant, one eye will be chosen as the study eye. Should eligibility apply to both eyes, the one with the lower BCVA during the screening will be selected.
The diagnosis must be confirmed with fluorescein and/or indocyanine green angiography.
The BCVA should be between 78 - 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at day 1.

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Exclusion Criteria

Participation in another clinical trial during the last 4 weeks.
Simultaneous participation in another clinical trial.
Subjects who receive any intraocular surgery during the study period on the study eye.
Pregnancy or breast-feeding.
Current chemotherapy.
Known intolerance/hypersensitivity to aflibercept 8 mg.
Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid (retinal detachment, diabetic maculopathy, epiretinal membrane with traction, central serous chorioretinopathy) on the study eye.
Retinal pigment epithelium (RPE) tear involving the macula on the study eye on day 1.
>6 diopters of myopia on the study eye (For patients who have undergone previous refractive or cataract surgery, the preoperative refractive error should not have exceeded −6 diopters of myopia).
Any cataract surgery within 3 months before day 1 or already scheduled during the study period on the study eye.
Any other intraocular surgery on the study eye (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant).
Polypoidal choroidal vasculopathy (PCV) or type 3 AMD confirmed by fluorescein and/or indocyanine green angiography on the study eye.