A Study to Evaluate Gene Therapy to Treat Neovascular Age-related Macular Degeneration

Overview

About this study

The primary objective of this study is to evaluate mean change in best-corrected visual acuity (BCVA) of RGX-314 relative to ranibizumab at Week 38.

Second objectives of this study are to evaluate the safety and tolerability of RGX-314 through Week 102, to evaluate the effect of RGX-314 relative to ranibizumab on BCVA, to evaluate the effect of RGX-314 relative to ranibizumab on central retinal thickness (CRT) as measured by spectral domain-ocular coherence tomography (SD-OCT), to evaluate the effect of RGX-314 relative to ranibizumab on center point thickness (CPT) as measured by SD-OCT, to assess the need for supplemental anti-vascular endothelial growth factor (VEGF) therapy in the RGX-314 treatment arms, to assess aqueous protein concentrations of RGX-314, and to evaluate the immunogenicity of RGX-314.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Age ≥ 50 years and ≤ 89 years

2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye

3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with
anti-VEGF

4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.

5. Willing and able to provide written, signed informed consent for this study

6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at
study entry

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to any causes other than AMD

2. Subfoveal fibrosis or atrophy in the study eye

3. Any condition in the investigator's opinion that could limit VA improvement in the
study eye

4. Active or history of retinal detachment in the study eye

5. Uncontrolled glaucoma in the study eye

6. History of intraocular surgery in the study eye within 12 weeks prior to Screening
Visit 1

7. History of intravitreal therapy in the study eye, such as intravitreal steroid
injection or investigational product, other than anti-VEGF therapy, in the 6 months
prior to Screening Visit 1.

8. Prior treatment with gene therapy.

9. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack
within the past 6 months.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/7/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sophie Bakri, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Jessica Morgan C.O.A.

(507) 293-9689

Morgan.Jessica@mayo.edu

More information

Publications

Publications are currently not available