A Randomized Double-Blind Study Comparing Bevacizumab and Aflibercept in Neovascular Age-Related Macular Degeneration Patients

The primary objective of the study is to determine if there is a difference in the number of **injections** required after two years in patients treated for **neovascular (wet) age-related macular degeneration (AMD)** with intravitreal injections of **bevacizumab** and **aflibercept**. This is clinically relevant as it may influence treatment protocols and patient management strategies by identifying the more efficient treatment option in terms of injection frequency, which can impact patient compliance and healthcare resource utilization.

Secondary objectives include evaluating differences in best-corrected visual acuity, macular thickness, recurrence interval, durability, cost efficiency, and vision-related quality of life. These factors are crucial for a comprehensive understanding of the treatment's impact on patient outcomes and the overall cost-effectiveness of the therapies.

The clinical trial focuses on individuals diagnosed with **neovascular (wet) age-related macular degeneration (AMD)**. The study population includes both male and female participants aged 50 years and older. Participants are required to have a diagnosis of the neovascular form of age-related macular degeneration, confirmed through clinical routine methods such as OCT-A and, if necessary, FA/ICG. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants' general health status and lifestyle considerations such as diet, physical activity, or habits are not specified. Key inclusion criteria include a signed informed consent and a distance visual acuity of 34 or higher (ETDRS) in the study eye. The selection process for the trial population is not detailed in the available data.

The clinical trial is a **randomized**, **double-blind**, controlled study designed to compare the efficacy of **bevacizumab** and **aflibercept** in patients with **neovascular (wet) age-related macular degeneration (AMD)**. The trial is conducted over a period of 24 months, with the primary objective of determining differences in the number of intravitreal injections required after two years of treatment. The study involves two pharmaceutical products: Avastin 25 mg/ml concentrate for solution for infusion and Eylea 40 mg/mL solution for injection in a vial, both administered via intravitreal use.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥50 years), diagnosis of neovascular AMD, and a minimum distance visual acuity of 34 ETDRS in the study eye. Following the screening, participants will be randomly assigned to receive either bevacizumab or aflibercept. Regular follow-up visits will be scheduled to monitor primary and secondary endpoints, including best-corrected visual acuity, macular thickness, intraocular pressure, recurrence intervals, and cost efficiency metrics. The end-of-study visit will conclude the trial, assessing the final outcomes and any adverse events.

The expected length of participant involvement is 24 months, aligning with the trial's duration. Conditions that may lead to early termination from the study include withdrawal of consent, significant protocol deviations, or adverse events that compromise participant safety. The trial is conducted in accordance with ethical standards and regulatory requirements, ensuring the integrity and reliability of the collected data.

The clinical trial involves the administration of **Avastin**, a **concentrate for solution for infusion** containing the active substance **bevacizumab**. This pharmaceutical form is specifically designed for **intravitreal use**. The dosage of Avastin is set at 1.25 mg per administration, with a maximum daily and total dose of 1.25 mg. The treatment period is capped at 24 months. Bevacizumab is a protein-based therapeutic agent, classified under the ATC code L01FG01. The product is manufactured by Roche Registration GmbH and is not formulated for pediatric use. Compliance with the dosing schedule is monitored throughout the study to ensure adherence to the protocol.

In comparison, the trial also utilizes **Eylea**, a **solution for injection** containing the active substance **aflibercept**. This medication is also administered via the **intravitreal route**. The dosage for Eylea is 2 mg per administration, with a maximum daily and total dose of 2 mg, and the treatment duration is similarly limited to 24 months. Aflibercept, like bevacizumab, is a protein-based therapeutic agent, and it is categorized under the ATC code S01LA05. The product is produced by Bayer AG and is not intended for pediatric use. Participant compliance with the dosing regimen is systematically monitored to ensure protocol adherence.

The efficacy of the clinical trial titled "The Sahlgrenska Anti-VEGF (SAHLVE) Study - a Prospective Randomized Double-blind Comparison of Bevacizumab and Aflibercept in Patients With Neovascular Age-related Macular Degeneration" will be assessed using both primary and secondary endpoints. The primary endpoint is the number of intravitreal injections administered after two years of treatment. This will provide a direct measure of the treatment frequency required for patients with **neovascular age-related macular degeneration** (AMD) when treated with either bevacizumab or aflibercept.

Secondary endpoints include a range of parameters to evaluate the broader impact of the treatments. These include best-corrected visual acuity (BCVA) measured by distance ETDRS and near LIX, macular thickness assessed by Central Retinal Thickness (CRT) in micrometers, and intraocular pressure (IOP) in mmHg. Additionally, the recurrence interval, defined as the maximum number of weeks from the last injection to relapse, will be recorded at both the first and last relapse. Durability, or the longest inactive interval detected in weeks, will also be evaluated. Economic assessments will be conducted through cost efficiency analysis using Quality-adjusted life years (QALY) measured with the EuroQol-5 Dimension (EQ-5D) questionnaire, and a cost-benefit analysis using the incremental cost-effectiveness ratio (ICER). Vision-related quality of life will be assessed using the NEI VFQ-25 questionnaire.