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Dry age-related macular degeneration – Trials in Disease

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Clinical Trials for Dry Age-Related Macular Degeneration

There are currently 11 ongoing clinical trials investigating new treatments for dry age-related macular degeneration, particularly geographic atrophy. These trials are testing various medications including eye injections, eye drops, oral tablets, and gene therapies across multiple European countries.

Clinical trial locations

Study of Pozelimab and Cemdisiran for Adults with Geographic Atrophy from Age-Related Macular Degeneration

This trial is evaluating two investigational medications, Pozelimab and Cemdisiran, for treating geographic atrophy, a form of advanced age-related macular degeneration that causes progressive vision loss.

Inclusion criteria: Participants must have geographic atrophy in one or both eyes, with affected areas measuring between 2.5 and 17.5 square millimeters. The atrophy should not involve the center of the fovea, the part of the retina responsible for sharp central vision. Vision must be at least 20/200 or better in the study eye. Participants need clear enough eye media and adequate pupil dilation for quality imaging. Both men and women can participate, and participants must be willing to complete a vaccination series for meningococcal and pneumococcal infections.

Exclusion criteria: People with other eye diseases that could affect results, recent eye surgery within three months, uncontrolled high blood pressure, severe kidney or liver disease, recent heart attack or stroke within six months, pregnancy or breastfeeding, or severe allergic reactions to medications cannot participate.

Treatment focus: The study examines whether Pozelimab and Cemdisiran, used alone or in combination, can slow the growth of damaged areas in the retina over 52 weeks. Both medications target Complement Component 5 (C5), part of the immune system that contributes to inflammation and tissue damage. Participants receive regular subcutaneous injections under the skin and undergo monitoring through specialized eye imaging and vision tests.

Investigational drugs: Pozelimab and Cemdisiran are both complement inhibitors that work by blocking the activity of Complement Component 5 in the immune system. This trial is testing whether reducing this immune response can slow disease progression.

Study on Long-term Safety of JNJ-81201887 for Patients with Geographic Atrophy Due to Age-related Macular Degeneration

This trial focuses on the long-term safety of JNJ-81201887, a gene therapy treatment for geographic atrophy. It is designed as a follow-up study for patients who have already participated in earlier research trials involving this treatment.

Inclusion criteria: Participants must have previously been involved in a parent clinical study and received either JNJ-81201887 or a sham treatment. They must sign an informed consent form to confirm their understanding of the study’s purpose and procedures. Both men and women who were enrolled in the previous trials are eligible.

Exclusion criteria: People with other eye diseases that could affect study results, recent or planned eye surgery, serious health conditions, pregnancy or breastfeeding, current participation in another trial, history of drug or alcohol abuse, or inability to follow study procedures are excluded.

Treatment focus: The study monitors the long-term safety and tolerability of JNJ-81201887, administered through an injection directly into the eye. Regular monitoring includes eye examinations, retinal imaging using various specialized techniques, clinical laboratory tests, and safety assessments. Some participants may also receive Prednisone tablets or matching placebo to manage inflammation.

Investigational drugs: JNJ-81201887 is a gene therapy that delivers genetic material to produce a protective protein in eye cells. It aims to slow the progression of lesions associated with geographic atrophy.

Study on the Effectiveness and Safety of GAL-101 Eye Drops for Patients with Geographic Atrophy from Age-Related Macular Degeneration

This trial is testing GAL-101, an eye drop solution, to see if it can slow the progression of non-foveal geographic atrophy, where the damaged area does not involve the central part of vision.

Inclusion criteria: Participants must be 55 years or older with non-foveal geographic atrophy confirmed through specialized imaging. The affected areas must be between 1.25 and 12.0 square millimeters, located outside the central fovea but within a specific radius from it. Vision must be at least 20/100 or better in the study eye. Participants need clear eye media for quality imaging and must be able to use the eye drops themselves or have assistance from a caregiver.

Exclusion criteria: The study excludes patients with geographic atrophy involving the central fovea or caused by new blood vessel growth, those outside the specified age range, or individuals considered part of vulnerable populations.

Treatment focus: The study evaluates whether GAL-101 eye drops can reduce the rate of growth of geographic atrophy areas over time. Participants are randomly assigned to receive either GAL-101 or a matching placebo. Regular assessments use fundus autofluorescence imaging and optical coherence tomography to measure changes in the retina, along with tests measuring macular sensitivity and vision.

Investigational drugs: GAL-101 is an ophthalmic solution designed to protect retinal cells by targeting specific pathways involved in their degeneration. It is applied as eye drops.

Study on Tinlarebant for Treating Geographic Atrophy in Patients

This trial examines Tinlarebant, an oral medication taken as a tablet, for its safety and effectiveness in treating geographic atrophy over a 24-month period.

Inclusion criteria: Participants must be between 60 and 85 years old with confirmed geographic atrophy. The atrophic lesions must measure between 0.5 and 10 square millimeters. If the lesions involve the central fovea, vision must be at least 20/80 or better; if not involving the fovea, vision must be at least 20/100 or better. The study eye must allow proper examination and quality imaging. Women of childbearing potential and men with partners who can become pregnant must use highly effective birth control throughout the study.

Exclusion criteria: People with other eye diseases affecting results, eye surgery within three months, current participation in another trial, severe allergic reactions to medications, pregnancy or breastfeeding, serious illnesses, or inability to follow study procedures are excluded.

Treatment focus: The study assesses whether Tinlarebant tablets, taken orally, can slow the growth rate of geographic atrophy lesions. Participants are randomly assigned to receive either Tinlarebant or matching placebo tablets. Regular follow-up visits over 24 months involve eye examinations, fundus autofluorescence imaging to measure lesion size, blood tests, and safety assessments.

Investigational drugs: Tinlarebant is a retinal protective agent that works by inhibiting specific pathways contributing to retinal cell degeneration. It is classified as an oral medication taken in tablet form.

Study of ONL1204 Eye Injections to Slow Vision Loss in Patients with Age-Related Macular Degeneration and Geographic Atrophy

This trial tests ONL1204, administered through injections directly into the eye, to determine if it can slow the progression of geographic atrophy in patients with age-related macular degeneration.

Inclusion criteria: Participants must be 55 years or older with non-foveal geographic atrophy that does not involve new blood vessel growth. Vision must be at least 24 letters on standard vision charts in the study eye and at least 19 letters in the other eye. Participants currently taking AREDS2 eye supplements must continue them throughout the study, while those not taking supplements should not start during the trial. Both men and women can participate.

Exclusion criteria: People with previous eye surgeries other than cataract surgery within three months, active eye infections or inflammation, other serious eye conditions affecting vision, recent participation in other trials, known allergies to similar medications, uncontrolled high blood pressure, pregnancy or plans to become pregnant, recent stroke within six months, recent cancer treatment, severe health conditions, inability to provide consent or follow procedures, or current drug or alcohol abuse cannot participate.

Treatment focus: The study evaluates whether ONL1204 eye injections can slow vision loss by monitoring changes in geographic atrophy areas over time. Participants receive intravitreal injections of either ONL1204 or sham injections as a control. Regular monitoring assesses changes in the affected retinal areas.

Investigational drugs: ONL1204 is a novel investigational medication being tested in Phase 2 clinical trials. It is administered through ocular injections and represents a new approach to treating geographic atrophy associated with age-related macular degeneration.

Long-Term Safety Study of GT005 for Patients with Geographic Atrophy Due to Age-Related Macular Degeneration Previously Treated in a Gyroscope Study

This trial monitors the long-term safety of GT005, a gene therapy treatment, for up to five years in patients who previously received it in earlier studies named FOCUS, EXPLORE, or HORIZON.

Inclusion criteria: Participants must have received GT005 in one of the previous studies. They must be able and willing to provide written informed consent and attend all study visits and assessments. Both men and women can participate, and the study is not intended for vulnerable populations.

Exclusion criteria: People who have not been treated with GT005 in previous studies, those with medical conditions other than geographic atrophy, or individuals from vulnerable populations cannot participate.

Treatment focus: The study focuses on identifying any ocular or systemic adverse events that may occur up to five years after treatment with GT005. Regular follow-up visits monitor participants for any side effects and assess their incidence and severity. GT005 is administered as a suspension for injection delivered directly under the retina.

Investigational drugs: GT005 is a gene therapy product that modulates the complement system, part of the immune response, to reduce inflammation and slow retinal damage progression. It aims to provide sustained therapeutic effects through genetic modification.

Study on Elamipretide for Patients with Dry Age-Related Macular Degeneration (Dry AMD)

This trial evaluates Elamipretide, administered through daily injections under the skin, for treating dry age-related macular degeneration characterized by photoreceptor loss.

Inclusion criteria: Participants must be adults aged 55 or older with at least one eye showing photoreceptor loss due to dry AMD. Women of childbearing potential must use reliable birth control, and men with female partners who can have children must use highly effective contraception. The affected area can have multiple spots. Participants must be able to administer the medication themselves and agree to all study requirements including daily medication, keeping a dosing diary, attending site visits, and undergoing examinations.

Exclusion criteria: People with other eye diseases that could affect results, eye surgery in the last three months, current use of other treatments for dry AMD, severe allergic reactions to medications, pregnancy or breastfeeding, participation in another trial in the last 30 days, or serious health conditions that could interfere with the study are excluded.

Treatment focus: The study assesses whether daily subcutaneous injections of Elamipretide can improve the condition of eyes affected by dry AMD. Participants receive either Elamipretide or placebo injections. Regular assessments at weeks 48, 72, and 96 use specialized imaging to measure changes in the macular area of photoreceptor loss and evaluate visual acuity improvements.

Investigational drugs: Elamipretide is a mitochondrial-targeting peptide that works by enhancing mitochondrial function within cells. It penetrates cell membranes to improve the energy-producing structures within cells, targeting mitochondrial dysfunction associated with dry AMD.

Study on JNJ-81201887 for Treating Geographic Atrophy in Age-related Macular Degeneration Patients

This trial examines whether JNJ-81201887, a gene therapy delivered through eye injections, can slow the growth of geographic atrophy lesions compared to a sham procedure.

Inclusion criteria: Participants must be 60 years or older with geographic atrophy that does not involve the center of the fovea. The affected area should measure between 2.5 and 17.5 square millimeters as determined by eye imaging. Women of childbearing potential must have a negative pregnancy test before starting. Participants must sign an informed consent form confirming their understanding of the study and ability to complete all assessments.

Exclusion criteria: Individuals without geographic atrophy cannot participate. Participants must be within the specified age range. Those considered part of vulnerable populations, such as individuals with certain disabilities or health conditions, may not be eligible.

Treatment focus: The study monitors changes in the size of affected retinal areas over time following intravitreal injection of JNJ-81201887 or sham procedure. Regular follow-up visits include eye examinations and imaging tests. Some participants may receive additional medications such as Prednisone tablets or Kenacort-A injections to manage inflammation.

Investigational drugs: JNJ-81201887 is a gene therapy that delivers genetic material to produce a protective protein in eye cells, aiming to slow lesion growth in geographic atrophy. It is administered through intravitreal injection directly into the eye.

Study on Long-Term Safety and Effects of Pegcetacoplan for Patients with Geographic Atrophy from Age-Related Macular Degeneration

This extension trial evaluates the long-term safety and effectiveness of Pegcetacoplan in individuals who have already participated in earlier trials of this medication for geographic atrophy.

Inclusion criteria: Participants must have completed a previous study called APL2-103 or finished treatment in studies APL2-303 or APL2-304. If they missed the last visit, they can still join if screened within 60 days of the expected last visit. Eyes must be clear enough for quality imaging. Women must either be unable to have children or have a negative pregnancy test and agree to use birth control during the study and for 90 days after the last dose, and not breastfeed. Men with female partners who can have children must use birth control and not donate sperm during the study and for 90 days after. Participants must be willing and able to give informed consent and follow all procedures and assessments.

Exclusion criteria: People with other eye diseases, eye surgery within three months, use of disallowed eye treatments, severe allergic reactions to medications, serious health conditions, pregnancy or breastfeeding, simultaneous participation in another trial, history of drug or alcohol abuse, or inability to follow procedures or attend visits are excluded.

Treatment focus: The study monitors long-term safety and measures changes in geographic atrophy area size and growth rate using fundus autofluorescence imaging. Secondary assessments include photoreceptor degeneration measurements using optical coherence tomography and vision sensitivity tests using mesopic microperimetry. Pegcetacoplan is administered through regular intravitreal injections into the eye.

Investigational drugs: Pegcetacoplan is a complement inhibitor that works by blocking a part of the immune system known as the complement pathway, which is involved in inflammation and tissue damage. It aims to slow the progression of vision loss.

Study on the Effectiveness and Safety of ANX007 Injections for Patients with Geographic Atrophy from Age-Related Macular Degeneration

This 24-month trial evaluates ANX007, given as monthly injections directly into the eye, to see if it can improve visual function and clarity in patients with geographic atrophy.

Inclusion criteria: Participants must have geographic atrophy confirmed by a doctor and reading center. The study eye is selected based on specific lesion size and characteristics. If the other eye is receiving approved treatment for geographic atrophy for at least three months, that treatment can continue. If treatment has been for less than three months, participants should not join. If the other eye is untreated, it should not need treatment for at least the first year according to medical opinion. Participants must be at least 50 years old and willing to participate in monthly visits for 24 months. The geographic atrophy lesion must measure between 2.5 and 17.5 square millimeters with specific imaging characteristics. Vision must be between 45 and 83 letters on ETDRS charts; if test results differ by 10 or more letters between two tests, participants are not eligible. Women must not be pregnant or breastfeeding and must use highly effective birth control or be unable to have children, with a negative pregnancy test before starting. Participants must be able to give signed consent and follow all study requirements.

Exclusion criteria: People with other eye diseases affecting vision, eye surgery in the past three months, severe allergic reactions to medications, current participation in another trial, uncontrolled high blood pressure, recent stroke or heart attack within six months, pregnancy or breastfeeding, serious illnesses, recent treatment for the condition within three months, or history of drug or alcohol abuse in the past year cannot participate.

Treatment focus: The study assesses whether monthly ANX007 intravitreal injections can improve visual function and visual acuity, helping patients see better and maintain vision. The primary evaluation between months 12 and 18 assesses the proportion of patients experiencing significant visual acuity loss. Secondary evaluations focus on adverse event incidence and severity through months 12 and 24.

Investigational drugs: ANX007 targets specific molecular pathways involved in macular degeneration progression, aiming to slow or halt vision deterioration. It is administered through intravitreal injection directly into the eye.

Study on the Safety of Avacincaptad Pegol for Patients with Geographic Atrophy Who Completed a Previous Study

This 18-month extension trial assesses the long-term safety of Avacincaptad Pegol in patients who completed the previous ISEE2008 (GATHER2) study.

Inclusion criteria: Participants must be 50 years or older with diagnosed geographic atrophy. They must have completed the ISEE2008 (GATHER2) study through the 24-month visit, whether they received the treatment or placebo. Participants must provide new written informed consent and be able to attend all trial visits for the entire 18-month duration.

Exclusion criteria: People who have not completed ISEE2008 (GATHER2) up to the 24-month visit or who have not been treated with either Avacincaptad Pegol or sham treatment in the previous study cannot participate.

Treatment focus: The study monitors long-term safety through regular follow-up visits over 18 months, assessing for any adverse effects and evaluating the body’s immune response to the medication and how it is processed. Participants receive monthly intravitreal injections of Avacincaptad Pegol, which works by inhibiting Complement C5, a part of the immune system, to slow damage progression.

Investigational drugs: Avacincaptad Pegol is a complement inhibitor that targets specific proteins in the immune system to prevent damage to the body’s own tissues. It is administered through intravitreal injection.

Summary

These 11 clinical trials represent significant research efforts across Europe to find effective treatments for dry age-related macular degeneration and geographic atrophy. The trials span multiple countries, with Germany, Spain, Italy, France, Hungary, and Poland hosting the most studies, reflecting a strong European commitment to researching this condition.

The investigational treatments employ diverse approaches including complement inhibitors targeting the immune system, gene therapies, mitochondrial-targeting peptides, and retinal protective agents. Most treatments are administered as intravitreal injections directly into the eye, though some trials test eye drops and oral tablets, offering potential alternatives for patients who may prefer different administration methods.

Several trials focus on long-term safety monitoring of treatments previously tested in earlier studies, demonstrating the importance of understanding how these medications perform over extended periods. The studies typically require participants aged 50 or older with specific characteristics of geographic atrophy, measured vision levels, and clear eye media for quality imaging.

Common exclusion criteria across trials include other eye diseases that could affect results, recent eye surgeries, pregnancy or breastfeeding, severe health conditions, and participation in other clinical trials. These trials collectively aim to slow the progression of geographic atrophy, preserve vision, and improve quality of life for patients affected by this condition.

Ongoing Clinical Trials on Dry age-related macular degeneration

  • Study of ONL1204 eye injections to slow vision loss in patients with age-related macular degeneration and geographic atrophy

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Germany Greece Hungary Italy +3

  • Study of Pozelimab and Cemdisiran for Adults with Geographic Atrophy from Age-Related Macular Degeneration

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Hungary Italy Poland +1

  • FWY003 in Geographic Atrophy Secondary to Age-Related Macular Degeneration in Patients

    Not yet recruiting

    1
    Investigated diseases:
    Bulgaria Czechia France Germany Hungary Italy +3

  • Study on Elamipretide for Patients with Dry Age-Related Macular Degeneration (Dry AMD)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Hungary Italy Spain

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