Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Ixo-vec
Aflibercept
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to provide informed consent (or have a legally authorizedrepresentative who is able and willing to provide informed consent) prior to anystudy assessments and procedures and comply with the study requirements and visits.
Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMDdisease activity at Screening Visit 1.
At least 50 years old at Screening Visit 1.
An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at ScreeningVisit 1.
Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening
Able to reliably use eye drops per protocol
Exclusion
Exclusion Criteria:
General Exclusion Criteria
History of a medical condition giving reasonable suspicion of a condition thatcontraindicates the use of Ixo-vec, compromises the participant's ability to complywith the planned study activities, or that might affect the interpretation of theresults of the study or render the participant at high risk for treatmentcomplications in the opinion of the Investigator. History of severe coronavirusdisease (COVID-19) infection may meet this exclusion criteria if, in the opinion ofthe Investigator, it is likely to lead to any important complications.
Received any prior gene therapy.
Prior treatment with any non-gene therapy investigational medicinal product (IMP) ormedical device in the study eye within 3 months of Screening Visit 1 or 5 half-livesof the IMP prior to dosing with Ixo-vec, whichever is longer.
Female participants who are pregnant or breastfeeding or who intend to becomepregnant or breastfeed in the future.
History or evidence of any of the following cardiovascular diseases:
Myocardial infarction in the 6-month period prior to Day 1.
Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg ordiastolic blood pressure > 100 mmHg.
Stroke in the 6-month period prior to Day 1.
History of ongoing bleeding disorders
Use of systemic immunosuppressive drugs within 90 days prior to Screening Visit 1.
Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% duringscreening
Ocular Exclusion Criteria
Any active ocular or periocular infection in the study eye from Screening Visit 1.
History or evidence of the following in the study eye:
Intraocular or refractive surgery within 90 days prior to Screening Visit 1 (Day -56 to Day -49).
Any previous penetrating keratoplasty or vitrectomy.
Any previous panretinal photocoagulation.
Any previous submacular surgery, other surgical intervention (including portdelivery system) or laser treatment for age related macular degeneration.
Any history or evidence of retinal detachment (with or without repair) or retinalpigment epithelium rip/tear in the study eye, as determined by the Investigatorduring screening or at Day 1.
Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1to Week 1.
Any history of intraocular pressure (IOP) elevation related to topical steroidadministration in either eye.
Any history of uveitis or inflammation (grade trace or above) except mildanticipated post operative inflammation that resolved in either eye.
Any history of treatment with complement inhibitors for geographic atrophy in thestudy eye.
Known history of ocular herpes simplex virus, varicella-zoster virus, orcytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.
Study Design
Study Description
Connect with a study center
Adverum Clinical Site 223
Gilbert, Arizona 85297
United StatesActive - Recruiting
Adverum Clinical Site 126
Phoenix, Arizona 85053
United StatesActive - Recruiting
Adverum Clinical Site 178
Phoenix, Arizona 85021
United StatesActive - Recruiting
Adverum Clinical Site 229
Scottsdale, Arizona 85255
United StatesActive - Recruiting
Adverum Clinical Site 159
Tucson, Arizona 85704
United StatesActive - Recruiting
Adverum Clinical Site 198
Springdale, Arkansas 72764
United StatesActive - Recruiting
Adverum Clinical Site 109
Bakersfield, California 93309
United StatesActive - Recruiting
Adverum Clinical Site 100
Beverly Hills, California 90211
United StatesActive - Recruiting
Adverum Clinical Site 201
Campbell, California 95008
United StatesActive - Recruiting
Adverum Clinical Site 172
Encino, California 91436
United StatesActive - Recruiting
Adverum Clinical Site 169
Fullerton, California 92835
United StatesActive - Recruiting
Adverum Clinical Site 164
Riverside, California 92505
United StatesActive - Recruiting
Adverum Clinical Site 140
Sacramento, California 95825
United StatesActive - Recruiting
Adverum Clinical Site 212
Sacramento, California 95841
United StatesActive - Recruiting
Adverum Clinical Site 175
Santa Barbara, California 93103
United StatesActive - Recruiting
Adverum Clinical Site 189
Walnut Creek, California 94598
United StatesActive - Recruiting
Adverum Clinical Site 200
Denver, Colorado 80222
United StatesActive - Recruiting
Adverum Clinical Site 116
Lakewood, Colorado 80228
United StatesActive - Recruiting
Adverum Clinical Site 165
Waterford, Connecticut 06385
United StatesActive - Recruiting
Adverum Clinical Site 184
Deerfield Beach, Florida 33064
United StatesActive - Recruiting
Adverum Clinical Site 176
Fort Lauderdale, Florida 33308
United StatesActive - Recruiting
Adverum Clinical Site 221
Fort Myers, Florida 33912
United StatesActive - Recruiting
Adverum Clinical Site 168
Jacksonville, Florida 32216
United StatesActive - Recruiting
Adverum Clinical Site 213
Orlando, Florida 32806
United StatesActive - Recruiting
Adverum Clinical Site 230
Pensacola, Florida 32503
United StatesActive - Recruiting
Adverum Clinical Site 124
Pompano Beach, Florida 33064
United StatesActive - Recruiting
Adverum Clinical Site 120
Saint Petersburg, Florida 33711
United StatesActive - Recruiting
Adverum Clinical Site 183
South Miami, Florida 33143
United StatesActive - Recruiting
Adverum Clinical Site 182
Augusta, Georgia 30909
United StatesActive - Recruiting
Adverum Clinical Site 149
'Aiea, Hawaii 96701
United StatesActive - Recruiting
Adverum Clinical Site 179
Oak Forest, Illinois 60452
United StatesActive - Recruiting
Adverum Clinical Site 207
Oak Park, Illinois 60304
United StatesActive - Recruiting
Adverum Clinical Site 195
Carmel, Indiana 46032
United StatesActive - Recruiting
Adverum Clinical Site 205
Carmel, Indiana 46032
United StatesActive - Recruiting
Adverum Clinical Site 197
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Adverum Clinical Site 204
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Adverum Clinical Site 167
Detroit, Michigan 48201
United StatesActive - Recruiting
Adverum Clinical Site 216
Madison, Mississippi 39110
United StatesActive - Recruiting
Adverum Clinical Site 163
Southaven, Mississippi 38671
United StatesActive - Recruiting
Adverum Clinical Site 190
Saint Louis, Missouri 63128
United StatesActive - Recruiting
Adverum Clinical Site 225
Liverpool, New York 13088
United StatesActive - Recruiting
Adverum Clinical Site 196
Asheville, North Carolina 28803
United StatesActive - Recruiting
Adverum Clinical Site 211
Greensboro, North Carolina 27401
United StatesActive - Recruiting
Adverum Clinical Site 209
Wake Forest, North Carolina 27587
United StatesActive - Recruiting
Adverum Clinical Site 219
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Adverum Clinical Site 181
Erie, Pennsylvania 16507
United StatesActive - Recruiting
Adverum Clinical Site 110
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Adverum Clinical Site 222
Ladson, South Carolina 29456
United StatesActive - Recruiting
Adverum Clinical Site 122
West Columbia, South Carolina 29169
United StatesActive - Recruiting
Adverum Clinical Site 123
Abilene, Texas 79606
United StatesActive - Recruiting
Adverum Clinical Site 127
Austin, Texas 78705
United StatesActive - Recruiting
Adverum Clinical Site 108
Bellaire, Texas 77401
United StatesActive - Recruiting
Adverum Clinical Site 227
Burleson, Texas 76028
United StatesActive - Recruiting
Adverum Clinical Site 194
Dallas, Texas 75231
United StatesActive - Recruiting
Adverum Clinical Site 188
Houston, Texas 77030
United StatesActive - Recruiting
Adverum Clinical Site 162
McAllen, Texas 78503
United StatesActive - Recruiting
Adverum Clinical Site 185
San Antonio, Texas 78240
United StatesActive - Recruiting
Adverum Clinical Site 107
The Woodlands, Texas 77384
United StatesActive - Recruiting
Adverum Clinical Site 199
Lynchburg, Virginia 24502
United StatesActive - Recruiting
Adverum Clinical Site 187
Wausau, Wisconsin 54403
United StatesActive - Recruiting
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