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Purpose

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

Conditions

Eligibility

Eligible Ages
Between 50 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥ 50 years and ≤ 89 years 2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye 3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF 4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye. 5. Willing and able to provide written, signed informed consent for this study 6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

Exclusion Criteria

  1. CNV or macular edema in the study eye secondary to any causes other than AMD 2. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC 3. Any condition in the investigator's opinion that could limit VA improvement in the study eye 4. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye 5. Advanced glaucoma or history of secondary glaucoma in the study eye 6. History of intraocular surgery in the study eye within 12 weeks prior to randomization 7. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1 8. Prior treatment with gene therapy 9. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
2 ABBV-RGX-314 treatment arms, 1 control arm (ranibizumab)
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The administration of ABBV-RGX-314 requires an outpatient surgical procedure performed in an operating room, while the active control, ranibizumab, is administered via intravitreal injection in an office setting. This study will be partially masked which will include masking of key study assessors and study drug dose.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ABBV-RGX-314 Dose 1 		ABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
  • Genetic: ABBV-RGX-314
    AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
Experimental
ABBV-RGX-314 Dose 2 		ABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
  • Genetic: ABBV-RGX-314
    AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
Active Comparator
Control Arm 		Ranibizumab administered via intravitreal injection approximately every 28 days
  • Biological: Ranibizumab (LUCENTIS®)
    0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days
    Other names:
    • Ranibizumab (anti-VEGF agent)

Recruiting Locations

118-Retinal Consultants of Arizona, Ltd.
Phoenix, Arizona 85053

170-Barnet Dulaney Perkins Eye Center
Sun City, Arizona 85351-2146

133-Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211

142-Retinal Diagnostic Center
Campbell, California 95008-6770

160-The Retina Partners - Encino
Encino, California 91436-2018

150-Retina Consultants of Orange County - Fullerton Office
Fullerton, California 92835

284- Salehi Retina Institute
Huntington Beach, California 92647-3601

187-Doheny Eye Institute - Doheny Eye Center
Los Angeles, California 90033-1035

132-Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View Office
Mountain View, California 94040

UCLA Doheny Eye Center
Pasadena, California 91105

185-California Eye Specialists Medical Group Inc. - Pasadena
Pasadena, California 91107

121-Retina Consultants San Diego
Poway, California 92064-2526

163-Retina Consultants
Sacramento, California 95819-3631

190-West Coast Retina Medical Group - San Francisco Office
San Francisco, California 94109-5520
Contact:
San Francisco 1 Location

137-UCSF Medical Center - Retina and Vitreous Clinic
San Francisco, California 94158

182-Orange County Retina Medical Group
Santa Ana, California 92705-3592

177-Retina Consultants of Southern Colorado PC- Colorado Springs
Colorado Springs, Colorado 80909-1183

141-Southwest Retina Consultants
Durango, Colorado 81301-5708

188-Colorado Retina Associates (CRA) - Red Rocks Medical Center Location
Lakewood, Colorado 80228

148-Vitreo Retinal Associates PA - The Millennium Center
Gainesville, Florida 32607-2586

205-Florida Retina Consultants - Lakeland
Lakeland, Florida 33805-2908

152-Retina Specialty Institute - Pensacola
Pensacola, Florida 32503-2030

165-Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
Saint Petersburg, Florida 33711-1141

278-Southern Vitreoretinal Associates, P.L.
Tallahassee, Florida 32308-4580

122-Southeast Retina Center
Augusta, Georgia 30909

145-Georgia Retina PC - Marietta
Marietta, Georgia 30060

295-Marietta Eye Clinic
Marietta, Georgia 30060

297- Thomas Eye Group
Sandy Springs, Georgia 30328

164 Retina Consultants of Hawaii (RCH) - Pali Momi Medical Center Location
'Aiea, Hawaii 96701-4723

183-University Retina and Macula Associates, P.C. - Lemont Office
Lemont, Illinois 60439-7421

184-University Retina and Macula Associates, PC - Oak Forest
Oak Forest, Illinois 60452

226-Springfield Clinic
Springfield, Illinois 62702

162-Midwest Eye Institute
Indianapolis, Indiana 46290-1167

186-Retina Associates, P.A. - Shawnee Mission
Lenexa, Kansas 66215

288 Ochsner Clinic Foundation
New Orleans, Louisiana 70121-2429

146-The Retina Care Center, LLC
Baltimore, Maryland 21209-2226

108-The Johns Hopkins Hospital - Wilmer Eye Institute - East Baltimore
Baltimore, Maryland 21287-0005

149-Cumberland Valley Retina Consultants (CVRC)
Hagerstown, Maryland 21740

106-Ophthalmic Consultants of Boston, Inc.
Boston, Massachusetts 02114

257-Retina Associates of Michigan - Grand Blanc Office
Grand Blanc, Michigan 48439-8301

153-Associated Retinal Consultants P.C.
Royal Oak, Michigan 48073

155-VitreoRetinal Surgery, PA - Edina Location
Minneapolis, Minnesota 55435
Contact:
Location

166-Mayo Clinic - Minnesota
Rochester, Minnesota 55905-0001

291-The Retina Institute
Saint Louis, Missouri 63128

119- Sierra Eye Associates
Reno, Nevada 89502-1605

125-Eye Associates of New Mexico - Albuquerque - Retina Center Location
Albuquerque, New Mexico 87109-5853

289- Retina Vitreous Surgeons of Central NY Syracuse
Liverpool, New York 13088

131-Duke Eye Center - Erwin Road - Duke University Medical Center
Durham, North Carolina 27705-4699

283-Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157

138-Cincinnati Eye Institute - Blue Ash
Cincinnati, Ohio 45242-5664

167-Retina Associates of Cleveland, Inc
Cleveland, Ohio 44130

173-Cleveland Clinic
Cleveland, Ohio 44195

175-Retina Vitreous Center (RVC)
Edmond, Oklahoma 73013

290- Verum Research, LLC
Eugene, Oregon 97401

143-Retina Northwest, PC
Portland, Oregon 97221-2421

252-Erie Retinal Surgery, Inc
Erie, Pennsylvania 16507-1429

105 Mid Atlantic Retina - Philadelphia
Philadelphia, Pennsylvania 19107-5109

210-Charleston Neuroscience Institute
Ladson, South Carolina 29456-4118

156-Black Hills Regional Eye Institute
Rapid City, South Dakota 57701

109-Charles Retina Institute
Germantown, Tennessee 38138-2405

144-West Texas Retina Consultants (WTRC) - Abilene Location
Abilene, Texas 79606

168-Austin Retina Associates
Austin, Texas 78705-1169

147-Retina Consultants of Austin
Austin, Texas 78705

157-Austin Clinical Research, LLC
Austin, Texas 78750-2302

293-Retina Consultants of Texas - Beaumont, TX
Beaumont, Texas 77707

286-Retina and Vitreous of TX PLLC
Bellaire, Texas 77401

189-Baylor Scott & White Surgicare
Burleson, Texas 76028-8338
Contact:
Location

139-Texas Retina Associates
Dallas, Texas 75231-5080

268-Retinal Consultants of San Antonio (RCSA) - Medical Center
San Antonio, Texas 78240-1657

117-Retina Consultants of Texas - The Woodlands
The Woodlands, Texas 77384-4167

161-Retina Associates of Utah, PC
Salt Lake City, Utah 84017

176-John A. Moran Eye Center - University of Utah Health Care
Salt Lake City, Utah 84112

140 Wagner Macula & Retina Center - Norfolk, VA Office
Norfolk, Virginia 23502

262-Retina Center Northwest - Silverdale
Silverdale, Washington 98383-7849

More Details

NCT ID
NCT04704921
Status
Recruiting
Sponsor
AbbVie

Study Contact

Patient Advocacy
(833) 711-0349
patientadvocacy@regenxbio.com

Detailed Description

This randomized, partially masked, active-controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of ABBV-RGX-314 relative to an active comparator. The primary endpoint of this study is the mean change from baseline in best-corrected visual acuity (BCVA) of ABBV-RGX-314 relative to ranibizumab at Week 54. Approximately 540 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.