Geographic Atrophy of the MaculaPhase 2eDREAMNCT06659549
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
A Phase 2 study testing GAL-101 in people with Geographic Atrophy of the Macula, run by Galimedix Therapeutics Inc at 24 sites in 8 countries.
Trial summary
Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Geographic Atrophy of the Macula
- What is being tested?
- GAL-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 10 Jan 2025to 30 May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥55 years of age
- Willing and able to provide written informed consent
- Willing and able to comply with the study schedule and study assessments
- Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution
- BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline
- Refractive error between +3 and -6 diopters spherical equivalent in the study eye
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- Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline
- Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center
- Well-delineated cumulative GA area between 1.25 and 12.0 mm2
- If GA is multifocal, at least 1 lesion ≥1.25 mm2
- GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium [RPE] and outer retina)
- GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea
- GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be >300 µm from image edges
- GA lesions must be >300 µm from the optic disc and/or peripapillary atrophy
- Area of PRD must be cumulatively between 7.25 and 25.0 mm2
Who cannot join
- Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
- History of laser therapy in the macular region, regardless of indication
- History of herpes zoster
- Ophthalmic disease or condition that requires or is likely to require surgery during the study period
- GA with cumulative area <1.25 mm2
- Any GA lesion within 100 µm radius from the center point of the fovea
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- Axial length >26 mm
- Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)
- Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period
- Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period
- Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period
- Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period
- Non-study Eye:
- BCVA of <5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
- Either Eye:
- History of uveitis
- GA secondary to any condition other than non-neovascular AMD
- History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline
- Underwent investigational treatment for AMD within 6 months before Visit 1a
- General Exclusion Criteria:
- History of therapeutic radiation to the cranium
- Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients
- History of malignant disease
- Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period
- Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period
- Use of lutein >10 mg per day or zeaxanthin >2 mg per day within 1 month before Visit 1a, or planned use during the study period
- Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data
- Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation
- Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline
- Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP
Trial locations and contacts
24 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Luciana Summo, PhD contact
24 sites in 8 countries
Germany6 sites, 6 recruiting
- Recruiting
Universitäts-Augenklinik Bonn
Bonn, 53127
Joanna Czauderna Study Coordinator, 0228 287-11493, Joanna.Czauderna@ukbonn.de
Kristina Pfau, MD
- Recruiting
Universitätsklinikum Freiburg Klinik für Augenheilkunde
Freiburg im Breisgau, 79106
Christine Kremer, +49 761 270 40231, christine.kremer@uniklinik-freiburg.de
Hansjuergen Agostini, MD
- Recruiting
Medizinische Hochschule Hannover Augenklinik
Hanover, 30625
Irene Oluwatoba-Popoola, Oluwatoba-popoola.irene@mh-hannover.de
Ekaterina Sokolenko, MD
- Recruiting
Dietrich Bonhoeffer Klinikum
Neubrandenburg, 17036
Ulrike Holland, +49 395 775 13427, aug-st2@dbknb.de
Christian Brinkmann, MD
- Recruiting
Universitätsklinikum Tübingen, Department für Augenheilkunde.
Tübingen, 72076
Angela Geiger, Felix.Reichel@med.uni-tuebingen.de
Felix Reichel, MD
- Not yet recruiting
UNIVERSITÄTSKLINIKUM ULM Klinik für Augenheilkunde
Ulm, 89075
Julia Ciboci, Julia.Ciboci@uniklinik-ulm.de
Armin Wolf, MD
France5 sites, 5 recruiting
- Recruiting
Centre Rétine Gallien
Bordeaux, 33000
Manon Demeurs, 33 (5) 56 11 32 25, arc@retinegallien.com
Eric Fourmaux, MD
- Recruiting
Hopital de La Croix-Rousse Service D'Ophtalmologie Groupement Hospitalier Nord Hospices Civils de Lyon
Lyon, 69317
Roxane Bai, +33 (0)4 26 73 27 02, roxane.bai@chu-lyon.fr
Laurent KODJIKIAN, MD
- Recruiting
Centre Monticelli Paradis d'Ophtalmologie
Marseille, 13008
Agné Devin Dr., 049116 05 84, agne.retine@gmail.com
François Devin, MD
- Recruiting
Centre Ophtalmologique Odéon
Paris, 75006
Sumeyye OZALTUN, ozalt.sumeyye@gmail.com
Favard, MD
- Recruiting
Centre médico-chirurgical de Touraine
Tours, 37540
Sarah Van Herreweghe, 33 (0)2 47 64 67 27, svanherreweghe6@gmail.com
Sam Razavi, MD
United States3 sites, 2 recruiting
- Recruiting
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Rahul Araza, (310) 289-2478 ext. 3, raraza@laretina.com
David Boyer, MD
- Suspended
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
- Recruiting
Bay Area Retina Associates
Walnut Creek, California, 94598
Karrie Padilla, 925-265-4146, kpadilla@bayarearetina.com
Roger Goldberg, MD
Italy3 sites, 3 recruiting
- Recruiting
Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
Milan, Milano, 20123
Mara Cattaneo Study Coordinator, mara.cattaneo@multimedica.it
Stela Vujosevic, MD
- Recruiting
Unità di Oculistica, IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Adelaide Pina Study Coordinator, 0226433545, pina.adelaide@hsr.it
Francesco Bandello, MD
- Recruiting
UOS Retina Medica, P.O. Britannico, IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
Roma, Roma, 00184
Ilaria Casale, Dr, ilaria.casale@fondazionebietti.it
Mariacristina Parravanno, MD
Georgia2 sites, 2 recruiting
- Recruiting
Akhali Mzera Limited
Tbilisi, 0162
Revaz Bezarashvili, (+995) 555 55 54 82, rezieye@gmail.com
Shalva Skhirtladze, MD
- Recruiting
Caucasus Medical Centre LLC
Tbilisi, 0186
Sopio Tsiklauri, MD, (+995) 595 974 774, soffia01@yahoo.com
Mikheil Omiadze, MD, PhD
Ireland2 sites, 2 recruiting
- Recruiting
UPMC Kildare Hospital Prosperous Rd Clane, Kildare Ireland
Kildare, W91 W535
Hiella Akhundova, +353 89 411 2119, hiella.a@ioes.ie
Eugene Ng, MD
- Recruiting
Institute of Eye Surgery (IOES Waterford)
Waterford, X91 DH9W
Emmanuel Ankamah, +353 89 411 2119, emmanuel.a@ioes.ie
Eugene Ng, MD
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
Michal Shpigel, 972-54-4575921, smichal@hadassah.org.il
Tareq Jaouni, MD
- Recruiting
Tel Aviv Medical Center
Tel Aviv, 6423906
Marina Gordon, 972-3-6947371, marinago@tlvmc.gov.il
Omer Trivizki, MD
Armenia1 site, 1 recruiting
- Recruiting
Ophthalmological Center After S.V. Malayan
Yerevan, 0048
Ani Babayan, +37494909990, babayanani88@yahoo.com
Lilit Voskanyan, MD, PhD
About this study
Official title: A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study
Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.
Read the detailed description
In this study, if both eyes qualify for the study, the eye with the better BCVA will be defined as the study eye. If both eyes qualify for the study and have identical BCVA, then the eye with higher baseline peripheral retinal degenerations (PRD) will be defined as the study eye. If baseline PRD is identical, then the right eye (OD) will be defined as the study eye. Only the study eye will be dosed with the Investigation Medicinal Product (IMP).
During visits, patients will administer 3 applications of 1 drop of GAL-101 or a matching Placebo that does not contain the active pharmaceutical ingredient (API) at 5-minute intervals (i.e., 1st application, wait 5 minutes, 2nd application, wait 5 minutes, 3rd application), under the supervision of trained and authorized study personnel. In between visits, patients will be instructed to administer 2 applications of 1 drop at 5-minute intervals once a day.
The study will be comprised of a 12- to 24-month treatment period determined individually according to patients' overall placement in global study randomization. All patients will participate at least 12 months of treatment. The visit schedule includes the following: Screening visits (Visit 1a and 1b) for image capture and confirmation of study eligibility by a reading center; Baseline/Randomization/Day 1 (Visit 2); a phone call at 2 weeks; and on-treatment clinic visits for safety and efficacy evaluations at 1 month, 3 months, 6 months, 9 months, and 12 months. Patients will continue to attend on-treatment clinic visits at 3-month intervals after 12 months until the last patient randomized in the study has completed 12 months of study treatment.
- Conditions
- Geographic Atrophy of the Macula
- Being tested
- GAL-101, Placebo
- Keywords
- AMD, Geographic Atrophy, Age Related Macular Degeneration, Amyloid-Beta, Eye-drops
- Medical subject headings
- Geographic Atrophy, Macular Degeneration, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAL-101Drug
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
PlaceboDrug
Patient will apply daily 2 eye drops of Placebo at 5 minutes interval
| Study group | Role | What they receive |
|---|---|---|
| GAL-101 ophthalmic solution | Experimental | Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval Receives: Drug: GAL-101 |
| Placebo | Placebo comparator | Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
Comparison between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF).
Measured: From baseline to last on-treatment visit (48 up to 96 weeks)
Secondary outcomes (1)
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA
Comparison between groups of annual rate of change in the area of PRD as measured by optical coherence tomography (OCT)
Measured: From baseline to last on-treatment visit (48 up to 96 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start10 Jan 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy of the MaculaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galimedix Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659549
- Sponsor's protocol ID
- GAL-101-C0201
- Acronym
- eDREAM
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided