A Phase 2, Multi-Center, Randomized, Double-Masked*, Active Controlled Study of ADVM-022
      (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema [INFINITY]

      *sponsor unmasked for enhanced safety monitoring as of May 2021

ADVM-022 Intravitreal Gene Therapy for DME

Diabetic Macular Edema

Diabetic Retinopathy

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of
      serious retinal vascular diseases including Diabetic Macular Edema (DME). DME affects up to
      10% of people with diabetes is caused by fluid accumulation in the macula and is the most
      frequent cause of sight loss in people with diabetic retinopathy. Available therapies for
      treating DME include laser and anti-vascular endothelial growth factor (anti-VEGF) drugs.
      Anti-VEGFs require frequent and long-term intravitreal (IVT) injections to achieve and
      maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat DME
      by providing durable expression of an anti-VEGF protein (aflibercept) to limit abnormal blood
      vessel leakage. ADVM-022 is designed to reduce the current treatment burden which often
      results in undertreatment, progression of disease and subsequent vision loss in patients with
      DME.

      In INFINITY, approximately 33 eligible subjects will be randomly assigned to receive one of
      the two doses of ADVM-022, or, assigned to the control arm to receive a sham ocular injection
      with a preceding aflibercept injection. Subjects who are assigned to receive ADVM-022 will be
      further randomized to receive a preceding aflibercept or sham ocular injection. All subjects
      will be assessed regularly and will receive additional aflibercept injections should DME
      disease activity progress.

      The primary objective is to assess the durability of a single intravitreal (IVT) injection of
      ADVM-022. All subjects will be followed for 96 weeks after randomization.

6E11 vg/eye of ADVM-022

2E11 vg/eye of ADVM-022

Aflibercept

A Phase 2, Multi-Center, Randomized, Double-Masked, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects With Diabetic Macular Edema [INFINITY]

Time to worsening of DME disease activity in the study eye.

Incidence and severity of ocular and non-ocular adverse events (AEs)

Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT

Frequency of rescue aflibercept (2 mg IVT) in the study eye over time during the study

Incidence of improvement in DRSS score over time

Incidence of worsening in DRSS score over time

Occurrence of vision threatening complication over time

Incidence of CST <300 μm over time through Week 48

Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation

6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT

2E11 vg/eye ADVM022 +/- aflibercept 2mg IVT

ADVM-022 Intravitreal Gene Therapy for DME

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status