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New treatment option for Age-related Macular Degeneration (AMD)
Official title A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
ClinicalTrials.gov ID: NCT06541704
What this study is testing
What is Pozelimab?
Pozelimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for age-related macular degeneration (amd).
Also referred to as REGN3918.
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
- This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
- Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
- BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
- Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the...
- Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and...
You likely can't join if
- GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine...
- History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye...
- Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT...
- Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3...
- Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that...
- Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic...
See the full eligibility criteria
- Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
- Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
- BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
- Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
- Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol Key
- GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
- History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol
- Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was...
- Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization
- Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study
- Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal...
- History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
- History of solid organ or bone marrow transplantation
- Use of chronic (\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol
- Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the...
- Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
- Carrier of Neisseria meningitidis based on culture collected during screening
- Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Springdale, Arkansas, United States
- Beverly Hills, California, United States
- Encino, California, United States
- Fresno, California, United States
- Fullerton, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Oxnard, California, United States
- Palm Desert, California, United States
- Pasadena, California, United States
- Poway, California, United States
+ 159 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 - 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, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Springdale, Arkansas, United States; Beverly Hills, California, United States and 173 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.