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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05536973
Other study ID # ADVM-022-11
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 23, 2022
Est. completion date November 2028

Study information

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

Clinical Trial Summary

Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.


Description:

This Phase 2, multi-center, randomized, double-masked, parallel group study is designed to evaluate the safety, tolerability, and efficacy of a single IVT injection of ADVM-022 at one of two doses (2 × 10^11 vg/eye [2E11] or 6 × 10^10 vg/eye [6E10]) accompanied by one of four prophylactic corticosteroid treatment regimens. Anti-VEGF treatment-experienced study participants meeting the eligibility criteria that will be randomized between the 2E11 vg/eye and 6E10 vg/eye ADVM-022 doses each with 4 prophylaxis arms for a total of 8 treatment arms, and only one eye per study participant will be selected as the study eye. Safety, tolerability, and efficacy will be evaluated for a period of approximately 5 years from baseline.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 69
Est. completion date November 2028
Est. primary completion date August 2028
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Male or female participants, = 50 years of age - Willing and able to provide written, signed informed consent for this study - Demonstrated a meaningful response to anti-VEGF therapy - Participants must be under active anti-VEGF treatment for wet AMD and received a minimum of 2 injections within 4 months prior to screening for the treatment of choroidal neovascularization secondary to nAMD in the study eye - Vision of the study eye at Baseline: BCVA in the range of 25 - 83 ETDRS letters, inclusive (approximate Snellen equivalent visual acuity range of 20/25 - 20/320) - Vision of the non-study eye at Baseline: BCVA = 35 ETDRS letters (approximate Snellen equivalent of 20/200 or better) Exclusion Criteria: - Any condition that could affect the interpretation of results or render the participant at high risk of treatment complications in the opinion of the Investigator - Ocular or periocular infection or intraocular inflammation in either eye within 1 month prior to or at the Randomization Visit (Day -7) - Uncontrolled diabetes or HbA1c = 7.0 % - History or evidence of significant uncontrolled concomitant disease within 6 months of the Screening visit - Any history of ongoing bleeding disorders or INR >3.0 - History or evidence of macular or retinal disease other than nAMD - History or evidence of retinal detachment or retinal pigment epithelium rip/tear - Uncontrolled ocular hypertension or glaucoma - Prior treatment with photodynamic therapy or retinal laser for the treatment of nAMD - Any history of vitrectomy or any other vitreoretinal surgery - Prior treatment with gene therapy at any time or any non-gene therapy investigational treatment or medical device in the study eye within 3 months of the Screening Visit or 5 half-lives of the investigational medicinal product

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
ADVM-022
A single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
ADVM-022
A single IVT injection of 6E10 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens

Locations

Country Name City State
France Adverum Clinical Site 500 Créteil Val-de-Marne
France Adverum Clinical Site 501 Lyon Rhône
France Adverum Clinical Site 502 Nantes Loire-Atlantique
United Kingdom Adverum Clinical Site 600 London
United Kingdom Adverum Clinical Site 601 Oxford
United States Adverum Clinical Site 149 'Aiea Hawaii
United States Adverum Clinical Site 123 Abilene Texas
United States Adverum Clinical Site 154 Austin Texas
United States Adverum Clinical Site 108 Bellaire Texas
United States Adverum Clinical Site 100 Beverly Hills California
United States Adverum Clinical Site 146 Cherry Hill New Jersey
United States Adverum Clinical Site 124 Deerfield Beach Florida
United States Adverum Clinical Site 167 Detroit Michigan
United States Adverum Clinical Site 172 Encino California
United States Adverum Clinical Site 176 Fort Lauderdale Florida
United States Adverum Clinical Site 169 Fullerton California
United States Adverum Clinical Site 168 Jacksonville Florida
United States Adverum Clinical Site 116 Lakewood Colorado
United States Adverum Clinical Site 162 McAllen Texas
United States Adverum Clinical Site 152 Morgantown West Virginia
United States Adverum Clinical Site 101 Nashville Tennessee
United States Adverum Clinical Site 177 Omaha Nebraska
United States Adverum Clinical Site 170 Pasadena California
United States Adverum Clinical Site 126 Phoenix Arizona
United States Adverum Clinical Site 178 Phoenix Arizona
United States Adverum Clinical Site 174 Poway California
United States Adverum Clinical Site 144 Rapid City South Dakota
United States Adverum Clinical Site 119 Reno Nevada
United States Adverum Clinical Site 164 Riverside California
United States Adverum Clinical Site 161 Royal Oak Michigan
United States Adverum Clinical Site 166 Sacramento California
United States Adverum Clinical Site 151 San Antonio Texas
United States Adverum Clinical Site 175 Santa Barbara California
United States Adverum Clinical Site 163 Southaven Mississippi
United States Adverum Clinical Site 171 Teaneck New Jersey
United States Adverum Clinical Site 107 The Woodlands Texas
United States Adverum Clinical Site 159 Tucson Arizona
United States Adverum Clinical Site 165 Waterford Connecticut
United States Adverum Clinical Site 122 West Columbia South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Adverum Biotechnologies, Inc. Parexel

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ocular and non-ocular adverse events Incidence of ocular and non-ocular adverse events Up to Week 52
Primary Severity of ocular and non-ocular adverse events Severity of ocular and non-ocular adverse events Up to Week 52
Primary Mean change in best corrected visual acuity (BCVA) from Baseline BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Baseline up to Week 52
Secondary Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in BCVA BCVA measured by ETDRS Baseline up to 5 years
Secondary Mean change in BCVA from Baseline BCVA measured by ETDRS Baseline up to 5 years
Secondary Percentage of participants who are supplemental aflibercept injection-free Supplemental anti-VEGF treatments required post therapy Baseline up to 5 years
Secondary Percent reduction in annualized anti-VEGF injections Supplemental annualized anti-VEGF treatments required post therapy to the year prior Baseline up to 5 years
Secondary Mean change in Central Subfield Thickness (CST) from Baseline To evaluate the effect of ADVM-022 on CST Baseline up to 5 years
Secondary Percentage of participants without CST fluctuations To evaluate the effect of ADVM-022 on CST Baseline up to 5 years
Secondary Mean number of CST fluctuations from Baseline To evaluate the effect of ADVM-022 on CST Baseline up to 5 years
Secondary Percentage of participants without post-prophylactic inflammation To assess the long-term safety and tolerability of a single IVT injection of ADVM-022 Baseline up to 5 years
Secondary Incidence of ocular and non-ocular adverse events To assess the long-term safety and tolerability of a single IVT injection of ADVM-022 Up to 60 months
Secondary Severity of ocular and non-ocular adverse events To assess the long-term safety and tolerability of a single IVT injection of ADVM-022 Up to 60 months
See also
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