Age-related macular degeneration - Trials in Disease – clinical trials

Study on Faricimab for Patients with Neovascular Age-Related Macular Degeneration Who Have Not Received Prior Treatment

This trial is investigating faricimab, marketed as Vabysmo, for patients with neovascular AMD who have never received treatment before. Faricimab is a protein-based medication that targets specific factors involved in abnormal blood vessel growth in the eye.

Main inclusion criteria: Participants must be 50 years or older with untreated neovascular AMD confirmed by special imaging techniques. The vision in the study eye should measure between 78 and 24 letters on a standardized vision chart. The abnormal blood vessel lesion must be nine or fewer disc areas in size, and the condition must be type 1 or type 2 AMD.

Main exclusion criteria: People with other eye diseases that could affect results, recent eye surgery within 3 months, uncontrolled high blood pressure, recent stroke or heart attack within 6 months, allergies to the study medication, pregnancy or breastfeeding, severe liver or kidney disease, or participation in another trial are not eligible.

Study focus: The trial evaluates how effective two initial doses of faricimab are in reducing disease activity. Participants receive injections directly into the eye and are monitored at weeks 4 and 8 to assess disease activity, vision changes, and retinal thickness. The study aims to determine the optimal treatment schedule, which could range from 4 to 16 weeks between doses.

Investigational drug: Faricimab works by blocking proteins that cause abnormal blood vessel growth, helping to reduce swelling and prevent further retinal damage.

Study on the Use of 68Ga-NODAGA-RGD for Monitoring Treatment in Patients with Age-Related Macular Degeneration

This French trial explores a new imaging technique using 68Ga-NODAGA-RGD PET scanning to monitor how well treatments are working in patients with AMD.

Main inclusion criteria: Participants must be 18 years or older with AMD in one eye, showing abnormal blood vessel growth on OCT scans. They must not have received any antiangiogenic treatment before and need to have health insurance or social security coverage. An initial eye examination including OCT and visual acuity testing must be completed within one month before the PET scan.

Main exclusion criteria: People with other eye diseases besides AMD, recent eye surgery within 3 months, known allergies to study substances, pregnancy or breastfeeding, serious illness that could interfere with the study, inability to follow study procedures, or current participation in another trial cannot join.

Study focus: The trial evaluates whether PET imaging can effectively show treatment response over three months. Participants receive regular antiangiogenic injections into the eye to reduce abnormal blood vessel growth. The imaging technique compares the affected eye with the unaffected eye to understand the relationship between imaging results and changes in eye structure and vision.

Investigational drug: 68Ga-NODAGA-RGD is a diagnostic imaging agent that helps visualize blood vessel activity in the eye, while intraocular antiangiogenic injections work to stop abnormal blood vessel growth and maintain vision.

Study on Treating Neovascular Age-Related Macular Degeneration with Aflibercept, Ranibizumab, and Brolucizumab for Patients with Active Disease

This Austrian study examines three different medications—Eylea (aflibercept), Lucentis (ranibizumab), and Beovu (brolucizumab)—for managing active neovascular AMD in real-world settings.

Main inclusion criteria: Participants must be 50 years or older with active neovascular AMD confirmed by imaging tests including OCT, OCTA, and fluorescein angiography. Vision in the study eye must be at least 0.1 (20/200) on the BCVA scale. There should be no significant fibrosis or geographic atrophy affecting the central part of the retina responsible for sharp vision.

Main exclusion criteria: Patients without neovascular AMD, those outside the specified age range, or belonging to vulnerable populations are excluded.

Study focus: The trial explores how automated tools can help assess and treat active neovascular AMD, potentially reducing the number of visits and treatments needed. Regular follow-up visits monitor the number of injections needed, visual acuity changes, retinal thickness, fluid volumes, and overall quality of life. The study continues until August 2025.

Investigational drugs: All three medications—aflibercept, ranibizumab, and brolucizumab—are injected into the eye and work by inhibiting abnormal blood vessel growth and reducing fluid leakage to preserve vision.

Long-term Safety and Effectiveness Evaluation of RGX-314 in Patients with Neovascular Age-related Macular Degeneration

This multi-country trial (Italy, France, Spain, Germany, and Hungary) evaluates the long-term safety and effectiveness of ABBV-RGX-314, a gene therapy approach for neovascular AMD.

Main inclusion criteria: Participants must have neovascular AMD and have previously received ABBV-RGX-314 in an earlier clinical study. They must be able and willing to provide written consent and follow all study procedures.

Main exclusion criteria: Pregnant, planning pregnancy, or breastfeeding women are excluded, as are people with interfering eye conditions like certain types of glaucoma or diabetic retinopathy, recent eye surgery within 30 days, active eye infection or inflammation, uncontrolled high blood pressure, allergies to study medications, current participation in another trial, significant medical conditions deemed unsafe by study doctors, immune system disorders, or recent stroke or heart attack within 6 months.

Study focus: The trial monitors participants who previously received this gene therapy to evaluate its long-term safety and effectiveness until July 2030. Regular follow-up visits assess vision using BCVA testing and measure central retinal thickness using specialized imaging. The study tracks how many additional anti-VEGF injections participants need over years 2, 3, 4, and 5. A Fellow Eye Treatment Substudy may offer treatment to the other eye of participants with AMD in both eyes.

Investigational drug: ABBV-RGX-314 is a gene therapy given through injection under the retina. It delivers a gene enabling eye cells to produce a protein that blocks VEGF, potentially reducing the need for frequent anti-VEGF injections currently required for wet AMD treatment.

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

This Spanish trial compares bevacizumab and ranibizumab while exploring how genetic differences might influence treatment response in AMD patients.

Main inclusion criteria: Participants must be 50 years or older with neovascular AMD and a recommendation from an ophthalmologist to receive anti-VEGF treatment. They must not have received any previous anti-VEGF treatment in the study eye.

Main exclusion criteria: People with other eye diseases affecting results, eye surgery in the last three months, allergies to study drugs or ingredients, current participation in another trial, uncontrolled high blood pressure, heart attack or stroke in the last six months, pregnancy or breastfeeding, history of drug or alcohol abuse, serious medical conditions that could interfere, or inability to follow procedures or attend visits are excluded.

Study focus: The double-blind trial determines if bevacizumab is as effective as ranibizumab after one year of treatment. Participants receive either medication through eye injections with regular check-ups to monitor vision and health. Saliva samples are collected to study genetic factors that might affect treatment response, specifically looking at genes that could influence how well treatments work for different individuals.

Investigational drugs: Both ranibizumab and bevacizumab are anti-VEGF medications that work by blocking proteins responsible for abnormal blood vessel growth in the eye, helping to reduce swelling and prevent further retinal damage.

Study on Faricimab and Aflibercept for Patients with Neovascular Age-Related Macular Degeneration Receiving Frequent Aflibercept Treatment

This Austrian trial compares faricimab to aflibercept (Eylea) in patients already receiving frequent aflibercept treatments, aiming to determine if treatment intervals can be extended.

Main inclusion criteria: Participants must be 50 years or older with neovascular AMD and have received at least seven previous anti-VEGF eye injections, with the last four being aflibercept administered within the last 35 days. The interval between the last two aflibercept injections must be 35 days or less. Vision should measure between 19 and 75 letters on the BCVA scale (roughly 20/400 to 20/32 vision).

Main exclusion criteria: People with other eye diseases affecting results, eye surgery within the last 3 months, uncontrolled high blood pressure, recent stroke or heart attack within 6 months, pregnancy or breastfeeding, allergies to study medications, or participation in another trial are excluded.

Study focus: The 56-week trial evaluates whether faricimab can extend the time between treatments compared to aflibercept while maintaining fluid-free retinas. Participants receive regular eye injections and are monitored to assess the presence of retinal fluid and treatment effectiveness, with key assessments at 32 weeks and 56 weeks.

Investigational drugs: Faricimab is an anti-VEGF and anti-angiopoietin therapy targeting proteins that contribute to abnormal blood vessel growth, while aflibercept is an established anti-VEGF therapy blocking proteins that promote abnormal blood vessel growth in the eye.

Age-related macular degeneration Trials in Disease

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