1-855-VIEWVISTA (1-855-843-9847)

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All travel for study-related assessments will be provided for eligible study participants and their caregiver
(if applicable).

The VISTA Trial is Pre-Screening Patients

ABOUT THE VISTA CLINICAL TRIAL

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.

Key Eligibility Criteria

To be eligible for the VISTA clinical trial, an individual must meet the following criteria1,2:

  • Be male with a diagnosis of XLRP confirmed by a qualified healthcare professional
  • Have a mutation in the RPGR gene confirmed by genetic testing
  • Be between the ages of 13 and 50 years old at the time of screening
  • Have best corrected visual acuity no better than 20/32 and no worse than 20/200 in at least one eye

Learn More or Refer a Patient

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.

Pre-Screening Opportunity for Patients with XLRP

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.

Why pre-screening can be a good idea for patients:

  • Pre-screening reduces the time burden and travel as many of the subjects who screen for the Vista trial may be required to travel long distances to the study site over the course of multiple weeks (3 total screening visits).
  • Patients can request access to their records and share with their providers

Participation in pre-screening is not required to participate in the VISTA clinical trial.

Key Eligibility Criteria for Pre-screening

  • Provide written (remote or in-person) informed consent, prior to the conduct of any pre-screening procedure
  • Be between 13-50 years of age at the time of informed consent and assent
  • Be male

LEARN MORE OR SEE IF YOUR PATIENTS QUALIFY FOR PRE-SCREENING

Free Genetic Testing Is Available

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.

What’s involved in participating?

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.

What can study participants expect?

  • Completion of initial pre-screening questionnaire (web-based and telephone)
  • Review of medical records by a study nurse to determine eligibility
  • Genetic testing to confirm XLRP with RPGR gene
  • On-site screening visits
  • Administration of investigational study therapy (if assigned to the treatment group)
  • Regular follow-up visits over the course of 5 years
  • All travel-related and study expenses for the patient and a study companion to be covered by the sponsor.

Refer a patient

About XLRP, a Rare Form of RP

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

About AGTC-501

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)

About AGTC

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

Learn More or Refer a Patient

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.