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Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]

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: NCT04645212
Recruitment Status : Active, not recruiting
First Posted : November 27, 2020
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Adverum Biotechnologies, Inc.

Tracking Information
First Submitted Date November 20, 2020
First Posted Date November 27, 2020
Last Update Posted Date February 14, 2023
Actual Study Start Date December 14, 2020
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2020)		 Type, severity and incidence of ocular and systemic adverse events (AEs). [ Time Frame: 156 weeks ]
Type, severity and incidence of ocular and systemic adverse events
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2020)
  • Change in best corrected visual acuity (BCVA) from baseline, over time [ Time Frame: 156 weeks ]
    Change in best corrected visual acuity (BCVA) from baseline, over time
  • Mean change in central subfield thickness (CST) and macular volume from baseline, over time [ Time Frame: 156 weeks ]
    Mean change in central subfield thickness (CST) and macular volume from baseline, over time
  • Percentage of subjects requiring supplemental aflibercept over time [ Time Frame: 156 weeks ]
    Percentage of subjects requiring supplemental aflibercept over time
  • Mean number of supplemental aflibercept injections over time [ Time Frame: 156 weeks ]
    Mean number of supplemental aflibercept injections over time
  • Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time [ Time Frame: 156 weeks ]
    Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
  • Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time [ Time Frame: 156 weeks ]
    Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
Official Title A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension
Brief Summary ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).
Detailed Description

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.

ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

To evaluate potential long-term outcomes of ADVM-022, the OPTIC-EXT will follow subjects previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 [OPTIC] (NCT03748784)). Subjects will roll over from the OPTIC parent study and will be followed for 3 additional years, following completion of the preceding 2-year assessment period in the OPTIC parent study. There is no investigational treatment administered in this study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • Subjects who received ADVM-022 at any dose in the OPTIC study
  • Up to 30 subjects from all cohorts of OPTIC
Condition
  • Wet Age-related Macular Degeneration
  • Neovascular Age-related Macular Degeneration
Intervention Biological: ADVM-022
Long term follow-up of subjects that received ADVM-022
Other Name: AAV.7m8-aflibercept
Study Groups/Cohorts 1
Subjects with wet AMD who received any dose of ADVM-022 in a prior clinical study.
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 Active, not recruiting
Actual Enrollment
 (submitted: February 13, 2023)		 23
Original Estimated Enrollment
 (submitted: November 20, 2020)		 30
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects who received a single dose of ADVM-022 at any dose in the OPTIC study
  • Willing and able to provide informed consent

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04645212
Other Study ID Numbers ADVM-022-07
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Current Responsible Party Adverum Biotechnologies, Inc.
Original Responsible Party Same as current
Current Study Sponsor Adverum Biotechnologies, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: OPTIC Medical Monitor Adverum Biotechnologies, Inc.
PRS Account Adverum Biotechnologies, Inc.
Verification Date February 2023