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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03748784
Other study ID # ADVM-022-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 14, 2018
Est. completion date June 22, 2022

Study information

Verified date August 2023
Source Adverum Biotechnologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Macular Degeneration
  • Neovascular Age-related Macular Degeneration
  • Wet Age-related Macular Degeneration

Intervention

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

Locations

Country Name City State
United States Adverum Clinical Site Abilene Texas
United States Adverum Clinical Site Bakersfield California
United States Adverum Clinical Site Beverly Hills California
United States Adverum Clinical Site Deerfield Beach Florida
United States Adverum Clinical Site Golden Colorado
United States Adverum Clinical Site Houston Texas
United States Adverum Clinical Site Nashville Tennessee
United States Adverum Clinical Site Philadelphia Pennsylvania
United States Adverum Clinical Site Reno Nevada
United States Adverum Clinical Site The Woodlands Texas
United States Adverum Clinical Site West Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Adverum Biotechnologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type, severity, and incidence of ocular and systemic adverse events (AEs) Type, severity, and incidence of ocular and systemic adverse events (AEs) 104 weeks
Secondary Change in best corrected visual acuity (BCVA) Change in best corrected visual acuity (BCVA) 104 weeks
Secondary Change in central subfield thickness (CST) and macular volume measured by SD-OCT Change in central subfield thickness (CST) and macular volume measured by SD-OCT 104 weeks
Secondary Percentage of subjects requiring anti-VEGF injections over time Percentage of subjects requiring anti-VEGF injections over time 104 weeks
Secondary Mean number of anti-VEGF injections over time Mean number of anti-VEGF injections over time 104 weeks
Secondary Percentage of subjects without intraretinal fluid over time Percentage of subjects without intraretinal fluid over time 104 weeks
Secondary Percentage of subjects without subretinal fluid over time Percentage of subjects without subretinal fluid over time 104 weeks
See also
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Completed NCT01926977 - Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration Phase 1/Phase 2
Recruiting NCT00370539 - Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD Phase 3
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Completed NCT03909425 - Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography
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Completed NCT05131646 - Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Completed NCT04537884 - Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration Phase 1
Completed NCT03216538 - Safety and Efficacy of AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD) Phase 1/Phase 2
Completed NCT04304755 - Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD) Phase 2
Completed NCT01958918 - Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD Phase 4
Active, not recruiting NCT01918878 - Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration. Phase 4
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