Ongoing Clinical Trials for Neovascular Age-Related Macular Degeneration

There are currently 16 clinical trials investigating new treatments for neovascular age-related macular degeneration across Europe. These studies are testing various medications delivered through eye injections, implants, and gene therapy approaches, with trials conducted in multiple countries including Germany, France, Spain, Italy, Poland, and others. (Also known as: wet AMD, nAMD, exudative age-related macular degeneration)

Clinical trial locations

Study of Faricimab Treatment Given Every 24 Weeks in Patients with Age-Related Macular Degeneration

This trial evaluates faricimab, a medication given as an injection into the eye to treat abnormal blood vessel growth affecting central vision. The study focuses on determining how well faricimab works and how safe it is when treatments are spaced up to 24 weeks apart.

Main inclusion criteria: Participants must be 50 years or older, in generally good health, and have untreated abnormal blood vessel growth in the eye with fluid present. Vision must be within a specific range, approximately 20/25 to 20/320, and eye structures must be clear enough for quality imaging.

Main exclusion criteria: People with recent eye inflammation or infection, previous anti-VEGF treatment within 3 months, uncontrolled high blood pressure, recent stroke or heart attack, recent eye surgery, other vision-affecting eye conditions, pregnancy or breastfeeding, known allergies to the study medication, or current participation in another trial are excluded.

Treatment focus: The study monitors vision changes and retinal thickness over 96 weeks. Treatment schedules are adjusted based on response, with intervals ranging from every 4 to 24 weeks. Regular vision testing and eye scans track medication effectiveness and safety.

Investigational drug: Faricimab works by targeting specific proteins that cause abnormal blood vessel growth in the eye. It is provided as a 120 mg/mL solution for injection directly into the eye.

Study on Long-Term Safety of Ranibizumab for Patients with Wet Age-Related Macular Degeneration Using a Port Delivery System

This trial studies the long-term safety of ranibizumab delivered through a port delivery system implanted in the eye. The system allows medication to be released over extended periods, potentially reducing the need for frequent injections.

Main inclusion criteria: Patients must have previously completed specific earlier studies involving ranibizumab treatment or the port delivery system. They must be able and willing to attend all scheduled visits and follow study procedures. Women of childbearing potential must use appropriate contraception.

Main exclusion criteria: Patients with other eye diseases affecting study results, recent eye surgery, eye infection or inflammation, allergies to study medication, current participation in another trial, serious illness, pregnancy or breastfeeding, or history of substance abuse are excluded.

Treatment focus: The study monitors participants who received ranibizumab through the port delivery system in earlier trials. It evaluates visual acuity changes, retinal fluid presence, and safety over time. Treatment intervals are adjusted between 24 and 36 weeks based on individual response.

Investigational drug: Ranibizumab blocks a protein that contributes to abnormal blood vessel growth in the eye. It is delivered through an implanted port delivery system at a concentration of 100 mg/mL.

Study on Vitrectomy, Alteplase, and Aflibercept for Patients with Wet Age-Related Macular Degeneration and Submacular Hemorrhage

This trial examines a combined treatment approach for bleeding under the central retina. The treatment includes surgery to remove eye gel, medication to dissolve blood clots, gas to help healing, and injections to reduce abnormal blood vessel growth.

Main inclusion criteria: Participants must be at least 50 years old and have bleeding under the retina affecting the center of vision, measuring at least one disc diameter in size. The bleeding must be at least 125 microns thick at the center. Vision must fall within a specific range measured by standard eye charts.

Main exclusion criteria: Patients with other eye diseases affecting results, recent eye surgery, allergies to study medications, pregnancy or breastfeeding, serious illness, inability to follow instructions, or current participation in another trial are excluded.

Treatment focus: The study compares combined surgical and medical treatment to standard anti-VEGF therapy alone. It measures vision improvement and overall eye health through regular follow-up visits and imaging tests.

Investigational drugs: Tissue plasminogen activator helps dissolve blood clots under the retina. SF6 gas holds the retina in place during healing. Anti-VEGF therapy blocks proteins causing abnormal blood vessel growth and leakage.

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

This study monitors patients who previously received ABBV-RGX-314 gene therapy in earlier trials. The treatment aims to help the eye produce proteins that reduce abnormal blood vessel growth, potentially decreasing the need for frequent injections.

Main inclusion criteria: Participants must have received ABBV-RGX-314 in a previous clinical study and be willing to follow all study procedures. They must be able to provide written informed consent.

Main exclusion criteria: Pregnant or breastfeeding women, patients with eye conditions affecting results, recent eye surgery, active infections, uncontrolled high blood pressure, allergies to study medications, current trial participation, recent stroke or heart attack, or immune system disorders are excluded.

Treatment focus: The study tracks long-term safety and effectiveness through regular vision assessments and retinal imaging. It monitors the need for additional anti-VEGF injections over years 2 through 5 of follow-up, with particular attention to side effects.

Investigational drug: ABBV-RGX-314 is a gene therapy delivered under the retina that enables eye cells to produce anti-VEGF protein. This approach may reduce the need for frequent injections by allowing the eye to manage the condition internally.

Study of BP05 and Ranibizumab Efficacy and Safety in Patients with Wet Age-Related Macular Degeneration

This double-blind study compares BP05 and Lucentis, both containing ranibizumab, to evaluate their effectiveness and safety. Neither participants nor doctors know which treatment is given to maintain objective results.

Main inclusion criteria: Patients must be at least 50 years old with active blood vessel growth under the retina confirmed by special eye tests. The affected area must be at least 50% of the total lesion. Vision must be between 20/40 and 20/200 on standard eye charts. Participants must agree to use effective birth control.

Main exclusion criteria: Patients with other eye diseases, recent eye surgery, current treatments for the condition, uncontrolled high blood pressure, severe allergic reactions, pregnancy or breastfeeding, recent participation in other trials, or serious health conditions are excluded.

Treatment focus: The study measures vision changes using standard eye charts and imaging tests at regular intervals including weeks 4, 8, 16, 24, and 52. It assesses the effectiveness of BP05 compared to Lucentis in improving vision and reducing disease-affected areas.

Investigational drugs: BP05 is a biosimilar candidate designed to work similarly to existing medication. Lucentis is an approved medication that inhibits abnormal blood vessel growth by blocking vascular endothelial growth factor.

Study on the Use of SB11 Pre-Filled Syringe for Patients with Wet Age-Related Macular Degeneration, Macular Edema from Retinal Vein Occlusion, or Myopic Choroidal Neovascularization

This study evaluates how well healthcare professionals can use a pre-filled syringe to administer Byooviz, containing ranibizumab, directly into the eye. The focus is on ease of use and treatment safety.

Main inclusion criteria: Participants must be at least 18 years old with one of three specific eye conditions suitable for ranibizumab treatment. They must provide informed consent and be willing to attend all visits. Women of childbearing potential must use appropriate contraception for at least three months after injection.

Main exclusion criteria: Patients with other eye diseases, recent or planned eye surgery, current eye infection or inflammation, allergies to study medications, current trial participation, serious health conditions, pregnancy or breastfeeding are excluded.

Treatment focus: The study monitors participants for one week after a single injection to assess side effects and vision changes. It evaluates how effectively healthcare professionals can follow preparation and administration instructions.

Investigational drug: SB11 is an anti-VEGF medication that inhibits abnormal blood vessel growth and leakage. It is administered as a 10 mg/mL solution through a pre-filled syringe designed for ease of use.

Study Comparing EYP-1901 and Aflibercept for Patients with Wet Age-Related Macular Degeneration

This double-masked trial compares an implant containing vorolanib with aflibercept injections. The study aims to determine if the implant can provide similar vision benefits while reducing treatment frequency.

Main inclusion criteria: Participants must be at least 50 years old, able to understand and sign informed consent, and willing to attend all visits. Women of childbearing potential or men with such partners must use appropriate contraception throughout the study.

Main exclusion criteria: Patients with other vision-affecting eye diseases, recent eye surgery or infection, allergies to study medications, pregnancy or breastfeeding, uncontrolled high blood pressure, recent stroke or heart attack, current trial participation, or conditions making participation unsafe are excluded.

Treatment focus: The study evaluates whether EYP-1901 can provide equivalent vision benefits as aflibercept over 56 weeks. It tracks retinal structure changes, additional injection needs, and overall eye health through 96 weeks.

Investigational drugs: EYP-1901 is a tyrosine kinase inhibitor delivered through an eye insert that blocks signals causing abnormal blood vessel growth. Aflibercept is an established anti-VEGF medication that prevents vision loss by blocking proteins promoting blood vessel formation.

Study Comparing RBS-001 and Aflibercept for Patients with Neovascular Age-Related Macular Degeneration

This trial compares RBS-001 and Eylea, both containing aflibercept, to determine if RBS-001 provides similar effectiveness and safety. The study uses fluorescein angiography to highlight blood vessels during assessments.

Main inclusion criteria: Participants must be at least 50 years old with active blood vessel growth under the retina confirmed by fluorescein angiography. The affected area must be at least 50% of the total lesion with retinal fluid present on optical coherence tomography. Vision must be between 34 and 73 letters on standard eye charts.

Main exclusion criteria: Patients with other eye diseases, recent eye surgery, current treatments for the condition, severe allergic reactions, uncontrolled high blood pressure, serious health conditions, pregnancy or breastfeeding, current trial participation, or substance abuse history are excluded.

Treatment focus: The study measures vision changes at weeks 4, 8, 12, 16, 20, and 24 using standardized tests. It assesses retinal fluid presence and blood vessel areas at 24 and 52 weeks to determine treatment effectiveness.

Investigational drugs: RBS-001 is being evaluated for equivalence to Eylea. Eylea is an established anti-VEGF medication that blocks proteins causing abnormal blood vessel growth and leakage in the eye.

Study of Aflibercept 8mg for Patients with Neovascular Age-Related Macular Degeneration Previously Treated with Faricimab and Aflibercept 2mg

This trial evaluates whether a higher 8 mg dose of aflibercept can extend treatment intervals for patients previously requiring frequent injections. The study aims to maintain eye health while reducing treatment frequency.

Main inclusion criteria: Participants must have participated in a previous specific study and be at least 50 years old with abnormal blood vessel growth due to the condition. Vision must be between 19 and 75 letters. Patients must have received at least four previous faricimab injections on a schedule of 35 days or less without achieving treatment extension.

Main exclusion criteria: Patients with other eye diseases, recent eye surgery, uncontrolled high blood pressure, recent stroke or heart attack, pregnancy or breastfeeding, allergies to study medication, current trial participation, or serious health conditions are excluded.

Treatment focus: The study monitors whether the higher dose can extend treatment intervals beyond 32 weeks while keeping the retina free of fluid. It tracks vision changes and injection frequency throughout the study period.

Investigational drug: Aflibercept is an anti-VEGF agent that reduces abnormal blood vessel growth and leakage. The study tests an 8 mg dose compared to the standard 2 mg dose to potentially extend time between treatments.

Study of OPT-302 and Aflibercept for Patients with Wet Age-related Macular Degeneration

This 96-week trial evaluates whether combining OPT-302 with aflibercept provides better outcomes than aflibercept alone. Some participants receive placebo to help determine true medication effects.

Main inclusion criteria: Participants must be at least 50 years old with active or adjacent abnormal blood vessel growth affecting the central retina. Vision must be between 60 and 25 letters on standard eye charts.

Main exclusion criteria: Patients with other eye diseases, recent eye surgery, current or recent treatments, severe allergic reactions, uncontrolled high blood pressure, serious health conditions, pregnancy or breastfeeding, current trial participation, or inability to follow procedures are excluded.

Treatment focus: The study measures vision changes from start to end, imaging assessments, and the overall effectiveness of combination therapy. Regular follow-up visits monitor eye health and treatment response.

Investigational drugs: OPT-302 is an anti-angiogenic agent that blocks specific proteins contributing to abnormal blood vessel growth. Aflibercept is an established anti-VEGF medication that prevents vision loss by inhibiting blood vessel formation proteins.

Study on Aflibercept for Adults with Diabetic Macular Edema or Wet Age-Related Macular Degeneration

This trial studies how the body processes aflibercept when injected in both eyes at a higher dose. It monitors medication levels in the blood to understand absorption and processing.

Main inclusion criteria: Participants must be at least 18 years old (or legal adulthood age in their country) and need anti-VEGF treatment in both eyes. Vision must be between approximately 20/32 and 20/320 with vision loss mainly due to the eye condition. Women of childbearing potential and sexually active men must use effective contraception for at least four months after treatment.

Main exclusion criteria: Patients with other eye diseases, recent eye surgery, current other treatments, severe allergic reactions, current trial participation, uncontrolled high blood pressure, recent heart attack or stroke, pregnancy or breastfeeding, serious medical conditions, or inability to follow procedures are excluded.

Treatment focus: The study involves regular blood tests to measure medication concentration after injections in both eyes. It assesses the maximum observed concentration and overall body processing of the higher dose.

Investigational drug: Aflibercept is an anti-VEGF agent administered at 8 mg per eye to study its processing when given in both eyes simultaneously. It works by inhibiting proteins that promote abnormal blood vessel growth.

Summary

These 16 clinical trials represent diverse approaches to treating neovascular age-related macular degeneration across Europe. Several notable patterns emerge from this overview.

Germany, France, Spain, and Italy appear most frequently as trial locations, suggesting strong research infrastructure and patient populations in these countries. Several trials span multiple European nations, indicating coordinated international research efforts.

The trials test various delivery methods including traditional eye injections, implanted port delivery systems, pre-filled syringes for easier administration, and innovative gene therapy approaches. Several studies focus on extending treatment intervals to reduce patient burden while maintaining effectiveness.

Anti-VEGF medications remain central to treatment strategies, with multiple trials comparing different formulations, doses, and delivery methods. Combination therapies appear in several studies, suggesting researchers are exploring whether multiple mechanisms of action can improve outcomes.

Most trials require participants to be at least 50 years old with specific vision ranges and exclude those with other eye diseases, uncontrolled health conditions, or recent eye surgery. Many studies monitor participants for extended periods, often up to two years or longer, to assess long-term safety and effectiveness.

These trials collectively aim to improve treatment options through longer-lasting effects, reduced injection frequency, and new therapeutic approaches for patients with this vision-threatening condition.

#1 Clinical Trials Search in Europe

Neovascular age-related macular degeneration – Trials in Disease

Ongoing Clinical Trials for Neovascular Age-Related Macular Degeneration

Clinical trial locations

Study of Faricimab Treatment Given Every 24 Weeks in Patients with Age-Related Macular Degeneration

Study on Long-Term Safety of Ranibizumab for Patients with Wet Age-Related Macular Degeneration Using a Port Delivery System

Study on Vitrectomy, Alteplase, and Aflibercept for Patients with Wet Age-Related Macular Degeneration and Submacular Hemorrhage

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

Study of BP05 and Ranibizumab Efficacy and Safety in Patients with Wet Age-Related Macular Degeneration

Study on the Use of SB11 Pre-Filled Syringe for Patients with Wet Age-Related Macular Degeneration, Macular Edema from Retinal Vein Occlusion, or Myopic Choroidal Neovascularization

Study Comparing EYP-1901 and Aflibercept for Patients with Wet Age-Related Macular Degeneration

Study Comparing RBS-001 and Aflibercept for Patients with Neovascular Age-Related Macular Degeneration

Study of Aflibercept 8mg for Patients with Neovascular Age-Related Macular Degeneration Previously Treated with Faricimab and Aflibercept 2mg

Study of OPT-302 and Aflibercept for Patients with Wet Age-related Macular Degeneration

Study on Aflibercept for Adults with Diabetic Macular Edema or Wet Age-Related Macular Degeneration

Summary

Ongoing Clinical Trials on Neovascular age-related macular degeneration

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Neovascular age-related macular degeneration – Trials in Disease

Ongoing Clinical Trials for Neovascular Age-Related Macular Degeneration

Clinical trial locations

Summary

Ongoing Clinical Trials on Neovascular age-related macular degeneration

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