Geographic Atrophy study: SAR446597
Official title A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT07215234
What this study is testing
What is SAR446597?
an investigational one-time intravitreal injection being studied as a potential treatment for geographic atrophy secondary to age‑related macular degeneration
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if a one‑time intravitreal injection of SAR446597 is safe, tolerable, and works to treat geographic atrophy.
- Who it's for
- Adults with geographic atrophy caused by age‑related macular degeneration.
- What's involved
- Participants receive a single injection into the eye (or a sham procedure) and have regular check‑ups and eye tests.
- Time commitment
- About 2 years of visits during the core study, followed by up to 3 additional years of follow‑up.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 60 years old or above
- Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)
- Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion...
- Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II).
You likely can't join if
- GA in the study eye caused by a disease different than AMD
- Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
- Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or...
- Current or history of systemic complement targeting treatment in the past 12 months
- Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting...
- History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
See the full eligibility criteria
- 60 years old or above
- Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)
- Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200
- Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II).
- GA in the study eye caused by a disease different than AMD
- Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
- Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or how well it works assessments
- Current or history of systemic complement targeting treatment in the past 12 months
- Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye
- History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
- History of active ocular infection in the study eye in 6 months prior to screening
- Presence of active ocular or periocular infections
- Active uncontrolled glaucoma in the study eye
- History of uveitis or scleritis in either eye
- Previous gene therapy in either eye
- Any significant poorly controlled illness that would preclude study compliance and follow up The above information is not intended to contain all considerations relevant to a patient's potential participation in a...
The study team makes the final eligibility decision.
Where it is enrolling
- Peoria, Arizona, United States
- Scottsdale, Arizona, United States
- Beverly Hills, California, United States
- Encino, California, United States
- Oxnard, California, United States
- Sacramento, California, United States
- Torrance, California, United States
- Walnut Creek, California, United States
- Gainesville, Florida, United States
- St. Petersburg, Florida, United States
- Stuart, Florida, United States
- Augusta, Georgia, United States
- Lemont, Illinois, United States
- Chevy Chase, Maryland, United States
- Hagerstown, Maryland, United States
- Towson, Maryland, United States
- Reno, Nevada, United States
- Wake Forest, North Carolina, United States
- Eugene, Oregon, United States
- Bethlehem, Pennsylvania, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Peoria, Arizona, United States; Scottsdale, Arizona, United States; Beverly Hills, California, United States; Encino, California, United States; Oxnard, California, United States; Sacramento, California, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.