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284 Participants NeededMy employer runs this trial

Ixo-vec for Age-Related Macular Degeneration

(AQUARIUS Trial)

Recruiting at 35 trial locations
AS
Overseen ByAdverum Study Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Adverum Biotechnologies, Inc.
Must be taking: Anti-VEGF therapy
Must not be taking: Systemic immunosuppressives
Disqualifiers: Pregnancy, Uncontrolled hypertension, Diabetes, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to intravitreal aflibercept (active comparator). The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured as an average at Weeks 52 and 56.

Safety, tolerability, and efficacy will be evaluated throughout the study.

Who Is on the Research Team?

AT

Adam Turpcu, PhD

Principal Investigator

Adverum Biotechnologies, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am at least 50 years old.
4. An ETDRS BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at Screening Visit 1.
I have shown improvement after anti-VEGF treatment.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravitreal injection of Ixo-vec or aflibercept, with additional loading doses and sham injections as per group assignment

56 weeks
3 monthly loading doses, followed by injections every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aflibercept
  • Ixo-vec

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ixo-vecExperimental Treatment2 Interventions
Group II: AfliberceptActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adverum Biotechnologies, Inc.

Lead Sponsor

Trials
10
Recruited
560+

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