Clinical Research Centre at St. Erik Eye Hospital

The Clinical Research Centre at St. Erik Eye Hospital offers experienced investigators in ophthalmology, access to a large and diverse patient population, as well as advanced imaging diagnostics and modern medical equipment in the heart of Stockholm.

A strong academic partnership with Karolinska Institutet creates the best conditions for successful clinical trials.

We have extensive experience in the preclinical and clinical development of advanced therapy medicinal products (ATMPs), both through investigator-initiated programs and in collaboration with leading pharmaceutical companies. The center provides a unique translational environment spanning discovery research, GMP manufacturing, regulatory interactions, and early-phase clinical trials.

Our services

We offer complete support for clinical studies and clinical drug trials in ophthalmology:

• Project management and study coordination
• Clinical examinations and advanced diagnostics
• Sampling and Sample Handling
• Data collection, eCRF and quality control
• Recruitment, booking and communication with study subjects
• Record keeping within the patient's regular care environment
• We conduct first-in-human phase 1 studies, where drugs including advanced therapies are given for the first time to humans, and can offer the opportunity to overnight research subjects.

Our goal is to deliver fast start-ups, high data quality and a seamless study flow.

Academic ATMP Development

• Over the past decade, St. Erik Eye Hospital and Karolinska Institutet have led the development of a stem cell-based therapy for advanced dry age-related macular degeneration (geographic atrophy). This program has progressed from basic research through preclinical development and has recently received regulatory approval for a first-in-human clinical trial (EU CT No. 2024-517546-33-00).

• In this study, human embryonic stem cell-derived retinal pigment epithelial cells (hESC-RPE) will be administered subretinally to patients with geographic atrophy. The investigational medicinal product (IMP) was manufactured under GMP conditions at the Vecura facility at Karolinska University Hospital and is cryopreserved pending shipment to St. Erik Eye Hospital, where the Phase 1 unit is located.  

Industry-Sponsored ATMP Trials

St. Erik Eye Hospital has substantial experience as a clinical site for advanced gene therapy trials in retinal disease.

• In collaboration with Novartis, the hospital served as the sole clinical site for a first-in-human gene therapy trial targeting RLBP1-associated retinitis pigmentosa (Bothnia dystrophy). Initiated in 2018, the study enrolled 12 patients who received a single subretinal administration of an AAV vector carrying a functional copy of the RLBP1 gene. Interim results were reported in 2024, and five-year follow-up was completed in 2026.
• Since 2023, St. Erik Eye Hospital has also participated in a Phase 2 gene therapy trial for geographic atrophy sponsored by Johnson & Johnson.

Together, these programs demonstrate the center's capability to develop, implement, and evaluate complex ATMPs across the full translational pathway—from laboratory discovery and GMP manufacturing to regulatory approval and first-in-human clinical testing. 

Contact

Please send your study request to: kfc.sankterik@regionstockholm.se

We will get back to you quickly and guide you through the next steps.

Office

Gauti Jóhannesson, Chief Medical Officer, Head of Clinical Research Centre

Amelie Ekegren, Research Coordinator

Ingvild Ulsaker-Janke, Research Coordinator