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ADVM-022 Intravitreal Gene Therapy for DME (INFINITY)

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ClinicalTrials.gov Identifier: NCT04418427
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Adverum Biotechnologies, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Diabetic Retinopathy Biological: 6E11 vg/eye of ADVM-022 Biological: 2E11 vg/eye of ADVM-022 Biological: Aflibercept Phase 2

Detailed Description:

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 48 weeks after randomization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-masked study. Subjects, outcomes assessors and the designated masked study personnel will be masked to subject's treatment assignment throughout the study. There must be a minimum of two physicians per site to fulfill the masking requirements of the study. A masked and unmasked investigator are required to be present for administration of the preceding dose of aflibercept or sham and following dose of ADVM-022 or sham visits, thereafter only the masked investigator is required to be present.
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Masked, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects With Diabetic Macular Edema [INFINITY]
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: 1
6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT
Biological: 6E11 vg/eye of ADVM-022
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
Other Name: AAV.7m8-aflibercept

Biological: Aflibercept
Commercially available Active Comparator
Other Name: Eylea

Experimental: 2
2E11 vg/eye ADVM022 +/- aflibercept 2mg IVT
Biological: 2E11 vg/eye of ADVM-022
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
Other Name: AAV.7m8-aflibercept

Biological: Aflibercept
Commercially available Active Comparator
Other Name: Eylea

Active Comparator: 3
Aflibercept 2mg IVT
Biological: Aflibercept
Commercially available Active Comparator
Other Name: Eylea




Primary Outcome Measures :
  1. Time to worsening of DME disease activity in the study eye. [ Time Frame: 48 weeks ]
    Time to worsening of DME disease activity in the study eye.


Secondary Outcome Measures :
  1. Incidence and severity of ocular and non-ocular adverse events (AEs) [ Time Frame: 48 weeks ]
    Incidence and severity of ocular and non-ocular adverse events (AEs)

  2. Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT [ Time Frame: 48 weeks ]
    Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT

  3. Change from Baseline in BCVA over time [ Time Frame: 48 weeks ]
    Change from Baseline in BCVA over time

  4. Frequency of rescue aflibercept (2 mg IVT) in the study eye over time during the study [ Time Frame: 48 weeks ]
    Frequency of rescue aflibercept (2 mg IVT) in the study eye over time during the study

  5. Incidence of improvement in DRSS score over time [ Time Frame: 48 weeks ]
    Incidence of improvement in DRSS score over time

  6. Incidence of worsening in DRSS score over time [ Time Frame: 48 weeks ]
    Incidence of worsening in DRSS score over time

  7. Occurrence of vision threatening complication over time [ Time Frame: 48 weeks ]
    Occurrence of vision threatening complication over time

  8. Incidence of CST <300 μm over time through Week 48 [ Time Frame: 48 weeks ]
    Incidence of CST <300 μm over time through Week 48

  9. Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation [ Time Frame: 48 weeks ]
    Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Type 1 or Type 2 diabetes mellitus
  • Willing and able to provide informed consent
  • Vision impairment due to center involving diabetic macular edema

Exclusion Criteria:

  • Uncontrolled diabetes defined as HbA1C >10%, or history of diabetic ketoacidosis within 3 months prior to randomization; or subjects who, within the last 3 months, initiated intensive insulin treatment (a pump or multiple daily injection) or plan to do so in the next 3 months.
  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
  • Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
  • Known severe renal impairment
  • High risk Proliferative Diabetic Retinopathy
  • History of retinal disease in the study eye other than diabetic retinopathy
  • History of retinal detachment (with or without repair) in the study eye
  • History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
  • Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
  • Current or planned pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418427


Contacts
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Contact: Heather Jividen +1(650) 649-1254 hjividen@adverum.com
Contact: Julie Clark, MD +1(650) 660-8964 jclark@adverum.com

Locations
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United States, Arizona
Adverum Clinical Site Recruiting
Phoenix, Arizona, United States, 85014
United States, California
Adverum Clinical Site Recruiting
Bakersfield, California, United States, 93309
Adverum Clinical Site Recruiting
Beverly Hills, California, United States, 90211
United States, Colorado
Adverum Clinical Site Recruiting
Golden, Colorado, United States, 80401
United States, Florida
Adverum Clinical Site Recruiting
Deerfield Beach, Florida, United States, 33064
United States, Nevada
Adverum Clinical Site Recruiting
Reno, Nevada, United States, 89502
United States, Pennsylvania
Adverum Clinical Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Adverum Clinical Site Recruiting
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Adverum Clinical Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Adverum Clinical Site Recruiting
Abilene, Texas, United States, 79606
Adverum Clinical Site Recruiting
Austin, Texas, United States, 78705
Adverum Clinical Site Recruiting
Houston, Texas, United States, 77030
Adverum Clinical Site Recruiting
The Woodlands, Texas, United States, 77384
Puerto Rico
Adverum Clinical Site Recruiting
Arecibo, Puerto Rico, 00612
Sponsors and Collaborators
Adverum Biotechnologies, Inc.
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Responsible Party: Adverum Biotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT04418427    
Other Study ID Numbers: ADVM-022-04
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adverum Biotechnologies, Inc.:
ADVM-022
ADVM-022-04
AAV.7m8
Anti-VEGF therapy
Blindness
INFINITY
Gene therapy
Aflibercept (Eylea)
Retinal Diseases
Eye Diseases
AAV Vector
Adverum
DME
Diabetic macular edema
Diabetic eye disease
Diabetic retinopathy
DR
AAV.7m8-aflibercept
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Edema
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases