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ADVM-022 Intravitreal Gene Therapy for Wet AMD (OPTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748784
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Adverum Biotechnologies, Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2018
First Posted Date  ICMJE November 21, 2018
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE November 14, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
Type, severity, and incidence of ocular and systemic adverse events (AEs) [ Time Frame: 104 weeks ]
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
Type, severity, and incidence of ocular and systemic adverse events (AEs) [ Time Frame: 24 weeks ]
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • Change in best corrected visual acuity (BCVA) [ Time Frame: 104 weeks ]
    Change in best corrected visual acuity (BCVA)
  • Change in central subfield thickness (CST) and macular volume measured by SD-OCT [ Time Frame: 104 weeks ]
    Change in central subfield thickness (CST) and macular volume measured by SD-OCT
  • Percentage of subjects requiring anti-VEGF injections over time [ Time Frame: 104 weeks ]
    Percentage of subjects requiring anti-VEGF injections over time
  • Mean number of anti-VEGF injections over time [ Time Frame: 104 weeks ]
    Mean number of anti-VEGF injections over time
  • Percentage of subjects without intraretinal fluid over time [ Time Frame: 104 weeks ]
    Percentage of subjects without intraretinal fluid over time
  • Percentage of subjects without subretinal fluid over time [ Time Frame: 104 weeks ]
    Percentage of subjects without subretinal fluid over time
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • Change in best corrected visual acuity (BCVA) [ Time Frame: 24 weeks ]
    Change in best corrected visual acuity (BCVA)
  • Change in central retinal thickness (CRT measured by SD-OCT) [ Time Frame: 24 weeks ]
    Change in central retinal thickness (CRT measured by SD-OCT)
  • Percentage of subjects requiring anti-VEGF injections through 104 weeks [ Time Frame: 104 weeks ]
    Percentage of subjects requiring anti-VEGF injections through 104 weeks
  • Mean number of anti-VEGF injections through 104 weeks [ Time Frame: 104 weeks ]
    Mean number of anti-VEGF injections through 104 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADVM-022 Intravitreal Gene Therapy for Wet AMD
Official Title  ICMJE An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration
Brief Summary ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.
Detailed Description This open-label, multicenter, dose-ranging study will evaluate 2 dose levels in up to 30 subjects (15 per dose) with active choroidal neovascularization (CNV) secondary to AMD. Subjects who are under active anti-VEGF treatment and have demonstrated a meaningful response to anti-VEGF therapy will be considered for participation in this study. The primary endpoint for this study is safety and tolerability of ADVM-022. All subjects will continue to be assessed for 104 weeks following treatment with ADVM-022.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Open-label, dose-ranging clinical study to evaluate the safety and tolerability of ADVM-022 in subjects with wet AMD.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wet Age-related Macular Degeneration
  • Neovascular Age-related Macular Degeneration
Intervention  ICMJE Biological: 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
Study Arms  ICMJE
  • Experimental: Dose 1
    6E11 vg of ADVM-022
    Intervention: Biological: ADVM-022
  • Experimental: Dose 2
    2E11 vg of ADVM-022
    Intervention: Biological: ADVM-022
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 11, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2018)
18
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 50
  • Diagnosis of neovascular (wet) AMD
  • BCVA ETDRS Snellen equivalent between ≤20/32 and ≥20/320 for each cohort
  • Subjects must be under active anti-VEGF treatment for wAMD and received a minimum of 2 injections within 4 months prior to screening
  • Demonstrated a meaningful response to anti-VEGF therapy
  • Willing and able to provide consent

Exclusion Criteria:

  • History of retinal disease in the study eye other than wet AMD
  • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement
  • History of retinal detachment (with or without repair) in the study eye
  • History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
  • Uncontrolled glaucoma in the study eye
  • Any prior treatment with photodynamic therapy or retinal laser for the treatment of wet AMD and any previous therapeutic radiation in the region of the study eye
  • Any previous intraocular or periocular surgery on the study eye within 6 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03748784
Other Study ID Numbers  ICMJE ADVM-022-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adverum Biotechnologies, Inc.
Study Sponsor  ICMJE Adverum Biotechnologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aaron Osborne, MBBS, MRCOphth Adverum Biotechnologies, Inc.
PRS Account Adverum Biotechnologies, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP