GCT to provide regulatory support for Novel Wet Age-related Macular Degeneration Treatment
GCT has been awarded a new regulatory project — an ophthalmological study for a Korean biotechnology company.
A novel wet age-related macular degeneration (Wet-AMD) treatment is to be investigated. The sponsor has requested GCT to provide the regulatory support services for the IND application prior to the clinical trials.
GCT’s regulatory group will perform the necessary activities to file the IND and proceed with required clinical trials in US and globally.
Wet age-related macular degeneration develops when abnormal blood vessels grow into the macula. The main risk factor for this disease is early vision loss. It’s important to have routine eye exams to identify early signs of macular degeneration.
Nevertheless, the progress does not stand still, and some forward-looking companies are developing treatments for patients with Wet-AMD.
“We appreciate the interest and trust of our clients, especially when it comes to ophthalmological studies, which GCT is very experienced in conducting,” said Eugene Selivra, MD, Chief Executive Officer.
Having conducted ophthalmology trials since early 2000s, both for big pharma and domestic biotech, GCT is well familiar with the key opinion leaders and fastest recruiting clinical sites in this therapeutic area. GCT will apply its expertise to ensure the successful completion of the client’s planned clinical program.