Study on the Effectiveness of Bevacizumab and Ranibizumab in Treating Age-Related Macular Degeneration in Patients with Genetic Variations

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What is this study about?

This clinical trial is focused on studying the effects of two treatments, Ranibizumab and Bevacizumab, for patients with Age-Related Macular Degeneration (AMD). AMD is a common eye condition that can lead to vision loss in older adults. The purpose of the study is to determine if Bevacizumab is as effective as Ranibizumab after one year of treatment for patients with AMD. Additionally, the study will explore how genetic differences, known as polymorphisms, might influence how patients respond to these treatments.

Participants in the study will receive either Ranibizumab or Bevacizumab through an injection into the eye, a method known as intravitreal use. The study will last for about a year, during which time participants will have regular check-ups to monitor their vision and overall health. Saliva samples will be collected to study genetic factors that might affect treatment response. This involves looking at specific genes that could play a role in how well the treatments work for different individuals.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment is being given to ensure unbiased results. By the end of the study, researchers hope to better understand the effectiveness of these treatments and the role of genetic factors in treating Age-Related Macular Degeneration.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history and a detailed eye examination to ensure you meet the criteria for participation.

3 treatment assignment

You will be randomly assigned to receive either bevacizumab or ranibizumab. Both medications are administered through an injection into the eye, known as intravitreal use.

4 treatment administration

The treatment involves regular injections. The frequency and dosage will be determined by the study protocol and your healthcare provider. This will continue for a duration of one year.

5 regular follow-up visits

You will have regular follow-up visits to monitor your response to the treatment. These visits will include eye examinations and assessments of your visual acuity, which is a measure of how well you can see.

6 genetic testing

A saliva sample will be collected to study genetic factors that may influence your response to the treatment. This involves using a swab to collect cells from the inside of your mouth.

7 final evaluation

At the end of the one-year treatment period, a final evaluation will be conducted. This will include a comprehensive eye examination and a review of your overall health and response to the treatment.

Who Can Join the Study?

Patients must be diagnosed with neovascular Age-related Macular Degeneration (a condition affecting the eyes).
Patients must be 50 years or older.
Patients must have a recommendation from an eye doctor (ophthalmologist) to receive treatment with an anti-VEGF agent (a type of medication used to treat eye conditions).
Patients must not have had any previous treatment in the eye being studied, specifically no prior anti-VEGF treatment for Age-related Macular Degeneration.

Who Cannot Join the Study?

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery in the last three months.
Patients who are allergic to the study drugs or any of their ingredients.
Patients who are currently participating in another clinical trial.
Patients who have uncontrolled high blood pressure.
Patients who have had a heart attack or stroke in the last six months.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have any serious medical conditions that could interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Hautiptj Du Lx Svvkq Cmgj I Seas Ptm	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	18.11.2022

Trial locations

Investigated drugs:

Ranibizumab is a medication used to treat a condition called Age-Associated Macular Degeneration (AMD), which affects the eyes and can lead to vision loss. It works by blocking a protein in the body that can cause abnormal blood vessels to grow in the eye, which can damage vision. In this clinical trial, Ranibizumab is being studied to see how effective it is in treating AMD and how genetic differences in patients might affect their response to the treatment.

Bevacizumab is another medication used in the treatment of Age-Associated Macular Degeneration (AMD). Like Ranibizumab, it helps prevent the growth of abnormal blood vessels in the eye that can harm vision. This trial is comparing Bevacizumab to Ranibizumab to determine if it is equally effective in treating AMD over a one-year period. The study also looks at how genetic variations in patients might influence their response to Bevacizumab treatment.

Investigated diseases:

Age-related macular degeneration

Age-Associated Macular Degeneration – Age-Associated Macular Degeneration is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp, straight-ahead vision. It typically progresses slowly and can lead to a gradual loss of central vision, making it difficult to read, drive, or recognize faces. The disease is characterized by the presence of drusen, which are yellow deposits under the retina, and can advance to more severe forms involving abnormal blood vessel growth or retinal atrophy. As the condition progresses, individuals may experience blurred or distorted vision, and in advanced stages, central vision may be significantly impaired. The progression of the disease varies among individuals, with some experiencing a slow decline in vision, while others may have a more rapid deterioration.

Trial ID:

2024-518990-33-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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