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Gene Therapy

Aflibercept for Diabetic Retinopathy (INFINITY Trial)

Phase 2
Waitlist Available
Research Sponsored by Adverum Biotechnologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights

INFINITY Trial Summary

This trial is testing a new treatment for diabetic macular edema (DME). The treatment is compared to the current standard of care, and patients are monitored for safety and efficacy.

Eligible Conditions
  • Diabetic Macular Edema
  • Diabetic Retinopathy

INFINITY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to worsening of DME disease activity in the study eye.
Secondary outcome measures
Change from Baseline in BCVA over time
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
+6 more

Side effects data

From 2015 Phase 4 trial • 26 Patients • NCT01617148
4%
Cataract progression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Group

INFINITY Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment2 Interventions
2E11 vg/eye ADVM022 +/- aflibercept 2mg IVT
Group II: 1Experimental Treatment2 Interventions
6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT
Group III: 3Active Control1 Intervention
Aflibercept 2mg IVT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
6E11 vg/eye of ADVM-022
2020
Completed Phase 2
~40
2E11 vg/eye of ADVM-022
2020
Completed Phase 2
~40
Aflibercept
2016
Completed Phase 4
~2540

Find a Location

Who is running the clinical trial?

Adverum Biotechnologies, Inc.Lead Sponsor
8 Previous Clinical Trials
236 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
22 Patients Enrolled for Diabetic Retinopathy
INFINITY Medical Monitor, MDStudy ChairAdverum Biotechnologies, Inc.
Hersh Patel, OD, MBA, FAAOStudy DirectorAdverum Biotechnologies, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Aflibercept's clinical trial history?

"Aflibercept was first studied in the year 2013 at Massachusetts General Hospital. Since then there are a total of 232 completed clinical trials. There are presently 51 actively recruiting clinical trials, with a large number of these trials based in Beverly Hills, California."

Answered by AI

How many people are currently enrolled in this research project?

"At the moment, this study is not looking for new patients to enrol. The trial was first announced on May 28th 2020 and has had one edit on January 10th 2022. There are currently 226 other trials searching for people with diabetic retinopathy and 51 trials involving Aflibercept that are admitting new participants."

Answered by AI

Is Aflibercept more toxic than other available treatments?

"While Phase 2 trials don't have data supporting efficacy, there is some safety data for aflibercept which earns it a score of 2."

Answered by AI

Could you please detail how many different places are managing this research?

"Presently, this study is enrolling patients from 13 clinical sites. These locations include Beverly Hills, Nashville and Philadelphia with an additional 10 situated throughout the country. When selecting a trial site, please choose the location closest to you in order reduce travel-related stressors."

Answered by AI

What conditions does Aflibercept usually help with?

"Aflibercept is most commonly used to help patients with wet age-related macular degeneration, but it can also be useful in managing symptoms of macular edema, diabetic macular edema, and general macular degeneration."

Answered by AI

Are any positions still available for participants in this experiment?

"This specific trial is no longer recruiting patients, as noted by the last edit date of January 10th, 2022. However, there are many other clinical trials with similar treatments that are still enrolling patients. For example, there are 226 active trials for diabetic retinopathy and 51 for Aflibercept"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ADVM-022 Intravitreal Gene Therapy for DME
2020. "ADVM-022 Intravitreal Gene Therapy for DME". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04418427.
~7 spots leftby Apr 2025
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