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The BETTER study
The Challenge:
Wet AMD causes reduced vision in the center of the eye and affects as many as 190 million people globally1.
Macular edema occurs when there is abnormal leakage and accumulation of fluid in the macula from damaged, dysfunctional blood vessels in the retina. A common cause of macular edema is diabetes, which is the leading cause of irreversible blindness in mature adults in the U.S2. Both diseases can be treated with a range of anti-VEGF drugs, however, these therapeutics are notable to maintain visual acuity as many patients develop fibrosis during the disease progression3.
- Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, et al. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013;1:e339–49.
- Bressler NM. Age-related macular degeneration is the leading cause of blindness. JAMA. 2004 Apr 21;291(15):1900-1. doi: 10.1001/jama.291.15.1900. PMID: 15108691.
- Isarna Therapeutics. Isarna Therapeutics Announces First Patient Enrolled in International Phase 2a Clinical Study in Ophthalmology Indications Wet AMD and DME. 2021. Here the press release.
The solution
Isarna has developed ISTH0036 to target the transforming growth factor-beta (TGF-β), a protein which is chronically elevated in ophthalmic, fibrotic, immunologic, and cancerous diseases. ISTH0036 suppresses TGF-β protein production production via well-studied antisense mechanisms.
Discovery® role
- Provide a same day data evaluation workflow for enrollment by reviewing clinical and imaging data between sites and reading center.
- RetinAI’s fluid and layer segmentation models are used to evaluate the primary endpoints (reduction of fluid and center macular thickness).
Check out Discovery for Clinical Studies
Study design
Targeted pathologies:
- wet age-related macular degeneration (wet AMD)
- diabetic macular edema (DME)
Type of patients included:
- Treatment-naïve patients newly diagnosed DME
- Treatment-naïve patients newly diagnosed nAMD
- nAMD patients VEGF responder (patients that experienced a reasonable response after receiving 3-5 anti-VEGF injections before inclusion in the study)
Key aspects:
phase 2a clinical study
9 months max duration (started mid-Nov 2021)
new drug: ISTH0036
60 patients
5 sites
6 image modalities per patient required (+1 optional)
8 acquisition devices used: Heidelberg Spectralis, Zeiss Plex Elite, Zeiss Clarus 6000, Optovue, HRA Spectralis,Haag-Streit, Topcon Triton, Eidon FA CenterVue
Partners
Check the other clinical studies we are involved in:
Check our Discovery for Clinical Studies
*Disclaimer
RetinAI Discovery is a CE-marked medical device according to the Medical Devices Regulation (EU) 2017/745
and the AI models are CE-marked devices according to Medical Devices Directive 93/42/EEC
RetinAI Discovery® is a 510(k) FDA Cleared medical device in US.
RetinAI Discovery® and Retinai® are both trademarks of RetinAI Medical AG.
The AI modules for biomarkers, fluid and layer segmentation and quantification
in retinal pathologies are for research use only in the USA.
The Advanced Segmentation and GA modules are for research use only.
Please be advised these tools are not intended to be a substitute for medical advice, diagnosis or treatment.
We do not warrant any reliance on the accuracy, completeness or usefulness of any content.
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