Oral CT1812 for Age-Related Macular Degeneration
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Cognition Therapeutics
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, your treatment for other chronic conditions must be stable for at least 30 days before screening.
What data supports the idea that Oral CT1812 for Age-Related Macular Degeneration is an effective treatment?
The available research does not provide specific data on the effectiveness of Oral CT1812 for Age-Related Macular Degeneration. Instead, it focuses on other treatments like pegaptanib and ranibizumab, which are used for the same condition. These studies discuss outcomes and effectiveness of these alternative treatments, but there is no direct information on Oral CT1812 in the provided research.
12345What safety data exists for CT1812 in treating age-related macular degeneration?
The provided research does not contain any safety data for CT1812, CT-1812, or Elayta in the treatment of age-related macular degeneration. The studies focus on other treatments such as pegaptanib and abicipar pegol, and the repurposing of other drugs for AMD.
16789Is the drug CT1812 a promising treatment for age-related macular degeneration?
The drug CT1812, also known as Elayta, is considered promising for treating age-related macular degeneration because it is being actively studied in clinical trials, which suggests it has potential benefits for patients with this eye condition.
1011121314Eligibility Criteria
This trial is for people over 50 with a specific eye condition called Geographic Atrophy due to dry Age-Related Macular Degeneration. Participants must have decent vision and stable health conditions. Those with recent eye surgeries, other serious eye diseases, or allergies to study drugs can't join.Inclusion Criteria
I am 50 years old or older.
BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts
My medication for other chronic conditions has been stable for at least 30 days.
Exclusion Criteria
My vision loss is not due to dry age-related macular degeneration.
I have a retinal disease that is not dry age-related macular degeneration.
I have an eye condition that might need surgery soon.
+8 more
Participant Groups
The study tests the effectiveness of an oral drug named CT1812 against a placebo in improving this eye condition. It's a double-masked trial, meaning neither participants nor researchers know who gets the real drug or placebo during the 104-week study.
2Treatment groups
Active Control
Placebo Group
Group I: CT1812 200 mgActive Control1 Intervention
Drug: CT1812 Active Study Drug
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NJ RetinaEdison, NJ
Bay Area Retina AssociatesWalnut Creek, CA
Advanced ResearchDeerfield Beach, FL
Advanced ResearchCoral Springs, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Cognition TherapeuticsLead Sponsor
References
RPE tears after pegaptanib treatment in age-related macular degeneration. [2022]To describe retinal pigment epithelial (RPE) tears in patients with age-related macular degeneration (AMD) status post pegaptanib (Macugen) injection.
Prevalence of age-related macular degeneration in the United States. [2022]To estimate the prevalence and distribution of age-related macular degeneration (AMD) in the United States by age, race/ethnicity, and gender.
Outcomes of persistently active neovascular age-related macular degeneration treated with VEGF inhibitors: observational study data. [2015]To describe outcomes of eyes with wet age-related macular degeneration (AMD) subdivided by lesion activity in a large multicentre cohort study.
NEOVASCULAR AGE-RELATED MACULAR DEGENERATION WITH ADVANCED VISUAL LOSS TREATED WITH ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY: Clinical Outcome and Prognostic Indicators. [2022]To describe visual outcome and prognostic indicators in neovascular age-related macular degeneration with advanced visual loss at the initiation of anti-vascular endothelial growth factor therapy.
24-month clinical outcomes of a treat-and-extend regimen with ranibizumab for wet age-related macular degeneration in a real life setting. [2018]To evaluate the clinical effectiveness and analyze the outcomes of a treat-and-extend (T&E) treatment regimen with ranibizumab for wet age-related macular degeneration (ARMD) in real life clinical settings over the first 2 years (24 months) of treatment.
Repurposing Drugs for Treatment of Age-Related Macular Degeneration. [2023]The need for new drugs to treat dry forms of age-related macular degeneration remains high. A promising approach is repurposing of FDA-approved medications to treat AMD. Databases containing medical and drug records allow for retroactive identification of drugs whose use correlates with reduced AMD diagnosis. This short review summarizes progress in several classes of drugs considered for repurposing: GPR-143 agonists (L-DOPA), anti-diabetic drugs (metformin, acarbose, empagliflozin, fenofibrate), mitochondrial activators (PU-91), and serotonin pathway drugs (fluoxetine, flibanserin, xaliproden, buspirone). The promises and caveats of repurposing are discussed herein.
Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Patients With Neovascular Age-Related Macular Degeneration: Studies in Japan and the United States. [2019]To evaluate comparability of abicipar pegol (abicipar) effects in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in Japan and the United States.
Intravitreal pegaptanib sodium for choroidal neovascularisation secondary to age-related macular degeneration: Pan-European experience. [2016]To evaluate visual outcomes in patients with neovascular age-related macular degeneration (NV-AMD) who were treated with pegaptanib sodium in European clinical ophthalmology practices.
Comparison of the effect between pegaptanib and ranibizumab on exudative age-related macular degeneration with small lesion size. [2021]To compare the effect of pegaptanib versus ranibizumab on exudative age-related macular degeneration (AMD) with small lesion size.
Evaluation of the clinical age-related maculopathy staging system. [2022]To evaluate a clinical classification system, the Clinical Age-Related Maculopathy Staging (CARMS) system, for age-related maculopathy (ARM) using a simple grading scale designed for clinical practice and clinical research protocols.
Optical coherence tomography predictors of progression of non-exudative age-related macular degeneration to advanced atrophic and exudative disease. [2022]To study the natural history of optical coherence tomography (OCT) imaging-based findings seen in non-exudative age-related macular degeneration (neAMD) and model their relative likelihood in predicting development of incomplete retinal pigment epithelium and outer retinal atrophy (iRORA), complete retinal pigment epithelium and outer retinal atrophy (cRORA), and neovascular AMD (nAMD).
Age-Related Macular Degeneration Staging by Color Fundus Photography vs. Multimodal Imaging-Epidemiological Implications (The Coimbra Eye Study-Report 6). [2020]Epidemiology of age-related macular degeneration (AMD) is based on staging systems relying on color fundus photography (CFP). We aim to compare AMD staging using CFP to multimodal imaging with optical coherence tomography (OCT), infra-red (IR), and fundus autofluorescence (FAF), in a large cohort from the Epidemiologic AMD Coimbra Eye Study. All imaging exams from the participants of this population-based study were classified by a central reading center. CFP images were graded according to the International Classification and Grading System for AMD and staged with Rotterdam classification. Afterward, CFP images were reviewed with OCT, IR, and FAF and stage update was performed if necessary. Early and late AMD prevalence was compared in a total of 1616 included subjects. In CFP-based grading, the prevalence was 14.11% for early AMD (n = 228) and 1.05% (n = 17) for late AMD, nine cases (0.56%) had neovascular AMD (nAMD) and eight (0.50%) geographic atrophy (GA). Using multimodal grading, the prevalence increased to 14.60% for early AMD (n = 236) and 1.61% (n = 26) for late AMD, with 14 cases (0.87%) of nAMD and 12 (0.74%) of GA. AMD staging was more accurate with the multimodal approach and this was especially relevant for late AMD. We propose that multimodal imaging should be adopted in the future to better estimate and compare epidemiological data in different populations.
Characteristics that Correlate with Macular Atrophy in Ranibizumab-Treated Patients with Neovascular Age-Related Macular Degeneration. [2023]To use multimodal assessment (fluorescein angiography [FA], color fundus photography [CFP], and spectral-domain-OCT [SD-OCT]) to reevaluate macular atrophy (MA) and macular neovascularization (MNV) type in the HARBOR trial according to the consensus on neovascular age-related macular degeneration (nAMD) Nomenclature criteria; and to determine if there are any associations between baseline demographic factors, ocular characteristics, and treatment for nAMD and the development of MA by month 24.
Genetic Risk Score Analysis Supports a Joint View of Two Classification Systems for Age-Related Macular Degeneration. [2023]The purpose of this study was to evaluate the utility of combining the Clinical Classification (CC) and the Three Continent age-related macular degeneration (AMD) Consortium Severity Scale (3CACSS) for classification of AMD.