The VISTA clinical trial is a Phase 2/3 study to assess the effect of AGTC 501 demonstrates improvement in a participant’s vision and other symptoms of XLRP. Patients that meet eligibility criteria and enroll into the VISTA trial will be assigned randomly (by chance) to either the treatment group or a control group. Patients assigned to the treatment group will receive an injection of either a low dose or a high dose of AGTC-501 in one eye. Neither the participant nor the study doctor will know which dose the participant has received. If a participant is assigned to the control group, they will be observed for one year before receiving an injection of AGTC-501 into one eye.
Enrollment is expected to begin Summer 2022. Pre-screening opportunities are available now for your eligible patients.
To be eligible for the VISTA clinical trial, an individual must meet the following criteria1,2:
For more information about our trials, including how your patients may participate, please contact us at 855-VIEWVISTA / (855) 843-9847, or click here to submit a form.
AGTC is offering patients a pre-screen option through 2020 Onsite. 2020 Onsite is a company that provides mobile vision services. The mobile vision clinic comes directly to your patient, eliminating the need for your patient to travel.
The mobile vision clinic provides the environment of fully operational clinic. Your patient can choose a day and time that works best for them. On their scheduled date, they will receive a visit from the mobile vision clinic. Your patient will receive exams by trained technicians in a private setting brought to their home or nearby location.
Participation in pre-screening is not required to participate in the VISTA clinical trial.
If your patient has been diagnosed with XLRP and has had the RPGR gene mutation confirmed through genetic testing, they may be eligible for the VISTA trial. However, if you are unsure whether your patient’s vision loss is due to XLRP and they have not received comprehensive genetic testing, your patient may qualify for free genetic testing and genetic counseling through AGTC.
Genetic testing is critical to the diagnosis and management of patients with inherited retinal diseases. AGTC is offering comprehensive testing of the RPGR gene, which is the most common gene associated with XLRP, at no cost to you or your patients.
Qualification for the study involves confirmation of XLRP with RPGR gene mutation by genetic testing and a medical record review to confirm if eligibility requirements are met. Patients will attend three separate screening visits at the study site to determine eligibility.
Retinitis pigmentosa (RP) describes a group of rare genetic eye diseases that damage light-sensitive cells in the retina, leading to loss of sight over time. In about 10% of RP cases, the nonworking gene is passed down from the mother to her male children, resulting in a form of RP known as X-linked RP (XLRP). XLRP causes gradual vision loss in boys and young men. The disease begins with night blindness and is followed by a slow narrowing of the peipheral field of vision. The decline in visual acuity results in legal blindness by the time the individual reaches their 40s.3
The VISTA clinical trial for XLRP involves a procedure with an investigational study drug, known as AGTC-501 (designated as rAAV2tYF-GRK1-RPGR), which is designed to replace the mutated RPGR gene that causes XLRP.3
Data from all 29 patients across 6 dose groups of the initial phase 1/2 XLRP clinical trial continues to demonstrate a favorable safety profile with no dose-limiting inflammatory responses observed. Further, a combined analysis of visual sensitivity data* from all centrally dosed patients shows robust and durable signs of improvement.†
For more information on our current clinical trials and data, please click here: News | Applied Genetic Technologies Corporation (agtc.com)
AGTC, the study sponsor, is a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases.
AGTC’S initial focus is in the field of ophthalmology, where it has active clinical trials in XLRP and achromatopsia (ACHM CNGB3 & ACHM CNGA3)4
For more information about our trial, including how your patients may participate, please contact us at 855-VIEWVISTA / (855) 843-9847, or click here to submit a form.
*Improvement in visual sensitivity is based on multiple measures including change from baseline in visual sensitivity of at least 7 decibels in at least 5 loci or a statistically meaningful improvement in sensitivity improvement profile between the treated and untreated eye. †Visual sensitivity, visual acuity, and safety data were reported for 12-month time points for Groups 2 and 4, and 6-month time points for Groups 5 and 6.
References: 1. Protocol AGTC-RPGR-001. Version 5.0. October 7, 2020. 2. . 3. AGTC website. X-linked retinitis pigmentosa. https://agtc.com/programs/x-linked-retinitis-pigmentosa. Accessed December 1, 2020. 4. AGTC Investors Web page. https://ir.agtc.com/. Accessed December 1, 2020.