Aurora (PQ-1123-001) is an ongoing Phase 1/2, double-masked, randomized, sham-controlled clinical trial of QR-1123 in adults with autosomal dominant retinitis pigmentosa, or adRP, due to the P23H mutation in the Rhodopsin (RHO) gene. QR-1123 is an investigational drug that is designed to stop the progression and potentially reverse the vision loss associated with this disease. Initial results from the study are expected in 2021.
Up to 35 adults will be included in Aurora. During the study patients receive up to four intravitreal injections of QR-1123 in one eye or a sham-procedure. Aurora is conducted at about seven expert clinical centers in North America.
The purpose of the Aurora study is to find out if different dose levels (amounts) of QR-1123, are safe in patients with adRP due to the P23H mutation the RHO gene. This study also measures whether QR-1123 results in any improvements to visual function (visual field, visual acuity and full field stimulation) or retinal structure (optical coherence tomography). Changes in quality of life, or patient reported outcomes, are also evaluated.
The 12-month trial includes single-dose escalation (open label) groups in which participants receive one dose of QR-1123 and multiple-dose escalation (double-masked) groups in which participants receive QR-1123 or sham procedures every three months (up to four times).
For questions, please contact ProQR Therapeutics Patient Advocacy via the contact form or email email@example.com.
Additional details about Aurora and where it is being conducted are available at www.clinicaltrials.gov and will be explained in detail by physicians conducting the trial.
What is a Phase 1/2 trial?
A trial may include more than one phase. A phase 1/2 clinical trial tests the safety of an investigational drug, as well as assesses signals of efficacy.
Combining phases 1 and 2 may allow research questions to be answered more quickly or with fewer patients.