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.
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.
- 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).
- 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)
phase 2a clinical study
9 months max duration (started mid-Nov 2021)
new drug: ISTH0036
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
RetinAI Discovery® and the AI models are CE-Marked medical devices according to the 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.
Discovery and AI Models are CE-Marked medical devices since April 2020 & December 2020 respectively.