AzTrials
AzTrials

AMDPhase 2/3ATMOSPHERENCT04704921

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

A Phase 2/3 study testing ABBV-RGX-314 and Ranibizumab (LUCENTIS®) in people with AMD and nAMD, run by AbbVie at 89 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 89 years
Conditions the study is for
AMD, nAMD, Wet Age-related Macular Degeneration
What is being tested?
ABBV-RGX-314 and Ranibizumab (LUCENTIS®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
671 participants
Where
89 sitesUnited States
Study dates
29 Dec 2020to Nov 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 50 years and ≤ 89 years
  • An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
  • Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
  • Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
  • Willing and able to provide written, signed informed consent for this study
  • Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
Show all 11Show fewer
  • An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes
  • Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes
  • Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes
  • Willing and able to provide written, signed informed consent for this study
  • Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study

Who cannot join

  • CNV or macular edema in the study eye secondary to any causes other than AMD
  • Subfoveal fibrosis or atrophy in the study eye, as determined by CRC
  • Any condition in the investigator's opinion that could limit VA improvement in the study eye
  • Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
  • Advanced glaucoma or history of secondary glaucoma in the study eye
  • History of intraocular surgery in the study eye within 12 weeks prior to randomization
Show all 18Show fewer
  • 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
  • Prior treatment with gene therapy
  • Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
  • CNV or macular edema in either eye secondary to any causes other than AMD
  • Subfoveal fibrosis or atrophy in either eye
  • Any condition in the investigator's opinion that could limit VA improvement in either eye
  • Active or history of retinal detachment, or current retinal tear that cannot be treated in either eye
  • Advanced glaucoma or history of secondary glaucoma in either eye
  • Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
  • History of intraocular surgery in either eye within 12 weeks prior to randomization (Week -2)
  • History of intravitreal therapy in either eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to screening
  • Prior treatment with gene therapy (*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.

Trial locations and contacts

89 sites in 1 country.

89 sites in 1 country

United States89 sites

  • Retina Consultants of Hawaii /ID# 256049

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas /ID# 256141

    Abilene, Texas, 79606-1224

  • Eye Associates of New Mexico /ID# 256075

    Albuquerque, New Mexico, 87109

  • Southeast Retina Center /ID# 256022

    Augusta, Georgia, 30909

  • Austin Research Center for Retina /ID# 256148

    Austin, Texas, 78705

  • Austin Retina Associates - Austin /ID# 256053

    Austin, Texas, 78705

  • Austin Clinical Research, LLC /ID# 256043

    Austin, Texas, 78750-2298

  • The Retina Care Center /ID# 256144

    Baltimore, Maryland, 21209

  • Johns Hopkins Hospital /ID# 256015

    Baltimore, Maryland, 21287

  • Retina Consultants of Texas - Beaumont /ID# 266279

    Beaumont, Texas, 77707

  • Retina and Vitreous of Texas /ID# 263961

    Bellaire, Texas, 77401

  • Pacific Northwest Retina /ID# 256155

    Bellevue, Washington, 98004

  • Retina Vitreous Assoc Med Grp /ID# 256299

    Beverly Hills, California, 90211

  • Ophthalmic Consultants of Boston /ID# 256014

    Boston, Massachusetts, 02114

  • Retinal Diagnostic Center /ID# 256137

    Campbell, California, 95008

  • The Retina Group Of Washington - Chevy Chase /ID# 276039

    Chevy Chase, Maryland, 20815

  • University of Illinois at Chicago /ID# 256300

    Chicago, Illinois, 60607

  • Retina Associates of Cleveland-Middleburg Heights /ID# 256052

    Cleveland, Ohio, 44130

  • Cleveland Clinic Main Campus /ID# 256064

    Cleveland, Ohio, 44195

  • Retina Consultants of Southern Colorado /ID# 256069

    Colorado Springs, Colorado, 80909

  • Texas Retina Associates - Dallas /ID# 256133

    Dallas, Texas, 75231

  • Advanced Research, LLC /ID# 275451

    Deerfield Beach, Florida, 33064-1342

  • Southwest Retina Research Center /ID# 256136

    Durango, Colorado, 81303

  • Duke Eye Center /ID# 256076

    Durham, North Carolina, 27705

  • Cincinnati Eye Institute- Edgewood /ID# 256132

    Edgewood, Kentucky, 41017-3415

  • VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256160

    Edina, Minnesota, 55435

  • Retina Vitreous Center, Research /ID# 256067

    Edmond, Oklahoma, 73013

  • The Retina Partners - Encino /ID# 256054

    Encino, California, 91436

  • Erie Retina Research /ID# 256154

    Erie, Pennsylvania, 16507

  • Verum Research, LLC /ID# 266585

    Eugene, Oregon, 97401

  • Baylor Scott & White Surgicare /ID# 256122

    Fort Worth, Texas, 76104

  • Retina Consultants of Orange County /ID# 256152

    Fullerton, California, 92835

  • Vitreoretinal Associates, P.A. /ID# 256150

    Gainesville, Florida, 32607

  • Charles Retina Institute /ID# 256016

    Germantown, Tennessee, 38138

  • Retina Associates of Michigan /ID# 266198

    Grand Blanc, Michigan, 48439

  • Long Island Vitreoretinal Consultants /ID# 256074

    Great Neck, New York, 11021

  • Cumberland Valley Retina Consultants - Hagerstown /ID# 256151

    Hagerstown, Maryland, 21740

  • Salehi Retina Institute /ID# 263485

    Huntington Beach, California, 92647

  • Retina Partners Midwest, PC /ID# 256045

    Indianapolis, Indiana, 46290

  • UC Irvine/Gavin Herbert Eye Institute /ID# 256145

    Irvine, California, 92697

  • Charleston Neuroscience Institute /ID# 256235

    Ladson, South Carolina, 29456

  • Florida Retina Consultants /ID# 265661

    Lakeland, Florida, 33805

  • Colorado Retina Associates /ID# 256121

    Lakewood, Colorado, 80228

  • University Retina and Macula Associates /ID# 256078

    Lemont, Illinois, 60439

  • Retina Associates - Lenexa /ID# 256080

    Lenexa, Kansas, 66215

  • University of Arkansas for Medical Sciences /ID# 271290

    Little Rock, Arkansas, 72205

  • Retina-Vitreous Surgeons of Central New York - Liverpool /ID# 266274

    Liverpool, New York, 13088

  • University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences /ID# 256159

    Madison, Wisconsin, 53705-3644

  • Georgia Retina - Marietta /ID# 256142

    Marietta, Georgia, 30060

  • Marietta Eye Clinic /ID# 268163

    Marietta, Georgia, 30060

  • Retina Associates of New Orleans /ID# 272440

    Metairie, Louisiana, 70006-2940

  • Bascom Palmer Eye Institute - University of Miami /ID# 256072

    Miami, Florida, 33136

  • Retina Vitreous Consultants - Monroeville /ID# 271654

    Monroeville, Pennsylvania, 15146

  • Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298

    Mountain View, California, 94040-4101

  • John-Kenyon American Eye Institute -New Albany /ID# 256065

    New Albany, Indiana, 47150-3620

  • Ochsner Medical Center - Jefferson Highway /ID# 270524

    New Orleans, Louisiana, 70121

  • Wagner Macula & Retina Center - Norfolk /ID# 256134

    Norfolk, Virginia, 23502

  • University Retina and Macula Associates /ID# 256077

    Oak Forest, Illinois, 60452

  • UCLA Doheny Eye Center /ID# 256120

    Pasadena, California, 91105

  • California Eye Specialists Medical Group Inc. /ID# 256079

    Pasadena, California, 91107

  • Retina Specialty Institute /ID# 256153

    Pensacola, Florida, 32503

  • Mid Atlantic Retina /ID# 256013

    Philadelphia, Pennsylvania, 19107

  • Retinal Research Institute /ID# 256019

    Phoenix, Arizona, 85053

  • Retina Northwest, PC /ID# 256140

    Portland, Oregon, 97221

  • Retina Consultants of San Diego /ID# 256021

    Poway, California, 92064-2530

  • Black Hills Regional Eye Institute /ID# 256161

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates /ID# 256020

    Reno, Nevada, 89502

  • Mayo Clinic - Minnesota /ID# 256051

    Rochester, Minnesota, 55905

  • Associated Retinal Consultants /ID# 256156

    Royal Oak, Michigan, 48073

  • Retinal Consultants Medical Group /ID# 256047

    Sacramento, California, 95825

  • Retina Associates of Utah /ID# 256044

    Salt Lake City, Utah, 84107

  • John A. Moran Eye Center /ID# 256068

    Salt Lake City, Utah, 84132

  • Retina Consultants Of Texas /ID# 268611

    San Antonio, Texas, 78240

  • Stone Oak Surgery Center /ID# 266199

    San Antonio, Texas, 78240

  • West Coast Retina /ID# 256448

    San Francisco, California, 94107

  • University of California, San Francisco /ID# 256130

    San Francisco, California, 94143

  • Thomas Eye Group PC /ID# 268159

    Sandy Springs, Georgia, 30328-4411

  • Orange County Retina Medical Group /ID# 256073

    Santa Ana, California, 92705

  • California Retina Consultants - Santa Barbara /ID# 256017

    Santa Barbara, California, 93103

  • Retina Center NW, PLLC /ID# 256157

    Silverdale, Washington, 98383

  • Retina Center Of Texas (Rct) - Southlake /ID# 256056

    Southlake, Texas, 76092

  • Springfield Clinic /ID# 266225

    Springfield, Illinois, 62702-3749

  • The Retina Institute /ID# 266587

    St Louis, Missouri, 46214

  • Retina Vitreous Associates of Florida - St. Petersburg /ID# 256050

    St. Petersburg, Florida, 33711-1141

  • Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055

    Sun City, Arizona, 85351

  • Southern Vitreoretinal Associates /ID# 256158

    Tallahassee, Florida, 32308

  • Retina Consultants - The Woodlands /ID# 256018

    The Woodlands, Texas, 77384

  • Retina Group of New England - Waterford /ID# 256071

    Waterford, Connecticut, 06385-1215

  • Atrium Health Wake Forest Baptist Medical Center /ID# 270767

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)

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.

Read the 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 630 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

A bilateral treatment substudy conducted at US sites is an open-label, partially randomized, parallel arm study to evaluate the safety and efficacy of subretinal ABBV-RGX-314 administered bilaterally in participants who have bilateral nAMD. Previously treated crossover participants from the control arm of the main study who crossed over and received ABBV-RGX-314 in the study eye will receive the same ABBV-RGX-314 dose in the contralateral eye (ie, same dose as in the study eye), and newcomers (participants who have not been randomized in an ABBV-RGX-314 study) and untreated crossover participants (ongoing control participants in the main study who have completed Week 54 but have not crossed over to receive ABBV-RGX-314 in the main study) will be randomized in a 2:1 ratio to receive ABBV-RGX-314 Dose 1 or ABBV-RGX-314 Dose 2 in both eyes. Up to 15 participants who qualify for the substudy will be enrolled and followed for a minimum of 50 weeks.

Being tested
ABBV-RGX-314, Ranibizumab (LUCENTIS®)
Keywords
Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Choroidal Neovascularization, Retinal Degeneration, Retinal Diseases, Eye Diseases, Ranibizumab, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Antineoplastic Agents, Gene therapy, Anti-vascular endothelial grown factory therapy, Anti-VEGF therapy
Medical subject headings
Choroidal Neovascularization, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-RGX-314Genetic

    Also called surabgene lomparvovec, RGX-314

    AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)

  • ABBV-RGX-314Genetic

    Also called surabgene lomparvovec, RGX-314

    AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)

  • Ranibizumab (LUCENTIS®)Biological

    Also called Ranibizumab (anti-VEGF agent)

    0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days

Study groups in NCT04704921
Study groupRoleWhat they receive
ABBV-RGX-314 Dose 1ExperimentalABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
Receives: Genetic: ABBV-RGX-314
ABBV-RGX-314 Dose 2ExperimentalABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
Receives: Genetic: ABBV-RGX-314
Control ArmActive comparatorRanibizumab administered via intravitreal injection approximately every 28 days
Receives: Biological: Ranibizumab (LUCENTIS®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in Best Corrected Visual Acuity (BCVA)

    BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)

    Measured: At Week 54

  2. Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs

    Incidence of ocular AEs and any SAEs

    Measured: Week 50

Secondary outcomes (38)

  1. Incidences of ocular and overall AEs over 54 weeks

    AEs over 54 weeks

    Measured: Through Week 54

  2. Incidences of ocular and overall AEs over 98 weeks

    AEs over 98 weeks

    Measured: Through Week 98

  3. Mean change from baseline in BCVA to Week 98 (ABBV-RGX-314 randomized participants) based on the ETDRS score

    BCVA measured by ETDRS

    Measured: Week 98

  4. Proportion of participants with worsened BCVA

    Proportion with worsened BCVA

    Measured: Week 54; Week 98

  5. Proportion of participants with improved BCVA

    Proportion with improved BCVA

    Measured: Week 54; Week 98

  6. Proportion of participants (1) gaining > 0 letters; (2) losing > 0 letters; maintaining vision (not losing ≥ 15 letters) compared with baseline as per BCVA

    Proportion gaining or losing > 0 letters based on ETDRS score; proportion maintaining vision

    Measured: Week 54; Week 98

  7. Mean change from baseline in BCVA for participants who received 0 or more supplemental anti-VEGF injections (ABBV-RGX-314 randomized participants)

    Mean change in BCVA based on ETDRS score for participants who received 0 or more supplemental anti-VEGF injection

    Measured: Week 54; Week 98

  8. Mean change from Week 54 to Week 98 in BCVA (control arm participants who cross over to ABBV-RGX-314)

    Mean change in BCVA based on ETDRS score

    Measured: Week 54 to Week 98

  9. Mean change from baseline in CRT as measured by SD-OCT

    Mean change in CRT as measured by SD-OCT

    Measured: Week 54; (ABBV-RGX-314 randomized participants) Week 98

  10. Mean change from Week 54 to Week 98 in CRT as measured by SD-OCT (control arm participants who cross over to ABBV-RGX-314)

    Mean change in CRT as measured by SD-OCT

    Measured: from Week 54 to Week 98

  11. Mean change from baseline in CPT as measured by SD-OCT

    Mean change in CPT as measured by SD-OCT

    Measured: Week 54; (ABBV-RGX-314 randomized participants) Week 98

  12. Mean change from Week 54 to Week 98 in CPT as measured by SD-OCT (control arm participants who cross over to ABBV-RGX-314)

    Mean change in CPT as measured by SD-OCT

    Measured: from Week 54 to Week 98

  13. Mean number of supplemental anti-VEGF injections from Baseline through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 98 (ABBV-RGX-314 randomized participants and control arm participants who cross over to ABBV-RGX-314)

    Mean number of supplemental anti-VEGF injections

    Measured: Through Week 98

  14. Proportion of participants with 0, 1, 2, and 3 supplemental injections through Week 54 and Week 98 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 98 (control arm participants who cross over to ABBV-RGX-314)

    Proportion of participants with 0, 1, 2, and 3 supplemental injections

    Measured: Through Week 98

  15. Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections through Week 54 and Week 98 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 98 (control arm participants who cross over to ABBV-RGX-314)

    Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections

    Measured: Through Week 98

  16. Proportion of participants that received 1 or 2 injections through Week 54 and Week 98 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 98 (control arm participants who cross over to ABBV-RGX-314)

    In the subset of participants who were given supplemental anti-VEGF injections, proportion of participants that received 1 or 2 injections

    Measured: Through Week 98

  17. Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate through Week 54 and Week 98 compared with the prior year (ABBV-RGX-314 randomized participants)

    Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate

    Measured: Through Week 98

  18. Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate through Week 54 and Week 98 compared with the prior year (ABBV-RGX-314 randomized participants)

    Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate

    Measured: Through Week 98

  19. Percent reduction in anti-VEGF injection annualized rate compared with the prior year (ABBV-RGX-314 randomized participants)

    Supplemental anti-VEGF injection annualized rate

    Measured: Through Week 54 and Week 98

  20. Supplemental anti-VEGF injection annualized rate through Week 54 and Week 98 (ABBV-RGX-314 randomized participants)

    Supplemental anti-VEGF injection annualized rate

    Measured: Through Week 54 and Week 98

  21. Percent reduction in anti-VEGF injection annualized rate after Week 58 through Week 98 relative to the year prior to the study (control arm participants who cross over to ABBV-RGX-314)

    Percent reduction in anti-VEGF injection annualized rate

    Measured: After Week 58 through Week 98

  22. Supplemental anti-VEGF injection annualized rate after Week 58 through Week 98 (control arm participants who cross over to ABBV-RGX-314)

    Supplemental anti-VEGF injection annualized rate

    Measured: After Week 58 to Week 98

  23. Time to first supplemental anti-VEGF injection after the Week 2 injection (ABBV-RGX-314 randomized participants)

    Time to first supplemental anti-VEGF injection

    Measured: Week 98

  24. Time to first supplemental anti-VEGF injection after the Week 58 injection (control arm participants who cross over to ABBV-RGX-314)

    Time to first supplemental anti-VEGF injection

    Measured: After Week 58 to Week 98

  25. Mean change from baseline in NEI-VFQ-25 (composite score) at Week 54 and (for ABBV-RGX-314 randomized participants and control arm participants who cross over to ABBV-RGX-314) Week 98

    Mean change in NEI VGQ-25 (composite score) at week 54 (control arm participants who cross over to ABBV-RGX-314)

    Measured: Week 54; Week 98

  26. Mean change from baseline in MacTSQ (composite score) at Week 54 and (for ABBV-RGX-314 randomized participants and control arm participants who cross over to ABBV-RGX-314) Week 98

    Mean change from baseline in MacTSQ (composite score) at week 54 and (control arm participants who cross over to ABBV-RGX-314) at Week 98

    Measured: Week 54; Week 98

  27. Aqueous ABBV-RGX-314 TP concentrations (ABBV-RGX-314 randomized participants)

    Aqueous ABBV-RGX-314 TP concentration

    Measured: Wk -2, Wk 14, Wk 26, Wk 38, Wk 54, and Wk 98

  28. Aqueous ABBV-RGX-314 TP concentrations (control arm participants who cross over to ABBV-RGX-314)

    Aqueous ABBV-RGX-314 TP concentration

    Measured: Wk 54, Wk 66, Wk 78, Wk 90, and Wk 98

  29. Immunogenicity measurements (ABBV-RGX-314 randomized participants)

    Immunogenicity measurements (serum antibodies to AAV8 and serum antibodies to ABBV-RGX-314 TP)

    Measured: Wk -2, Wk 14, Wk 26, Wk 38, Wk 54, and Wk 98

  30. Immunogenicity measurements (control arm participants who cross over to ABBV-RGX-314)

    Immunogenicity measurements (serum antibodies to AAV8 and serum antibodies to ABBV-RGX-314 TP)

    Measured: Wk 54, Wk 66, Wk 78, Wk 90, and Wk 98

  31. Bilateral Treatment Substudy: Incidence of nonocular AEs and any AEs of special interest

    Nonocular AEs and AEs of Special interest

    Measured: Week 50

  32. Bilateral Treatment Substudy: Mean change from Baseline in BCVA at assessed timepoints

    BCVA measured by ETDRS

    Measured: Through Week 50

  33. Bilateral Treatment Substudy: Mean change from Baseline in CRT at assessed timepoints

    Mean change in CRT as measured by SD-OCT

    Measured: Through Week 50

  34. Bilateral Treatment Substudy: Supplemental anti-VEGF injection annualized rate

    Supplemental anti-VEGF injection annualized rate

    Measured: Through Week 50

  35. Bilateral Treatement Substudy: Mean number of supplemental anti-VEGF injections

    Mean supplemental anti-VEGF injections

    Measured: Through Week 50

  36. Bilateral Treatment Substudy: Proportion of participants with 0, ≤ 1, ≤ 2, and ≤ 3 supplemental anti-VEGF injections

    Proportion of participants with 0, ≤ 1, ≤ 2, and ≤ 3 supplemental anti-VEGF injections

    Measured: Through Week 50

  37. Bilateral Treatment Substudy: Aqueous humor and serum ABBV-RGX-314 TP concentrations

    Aqueous humor and serum ABBV-RGX-314 TP Concentrations

    Measured: Wk 26, Wk 34, Wk 50

  38. Bilateral Treatment Substudy: Immunogenicity measurements (serum anti-ABBV-RGX-314 TP antibodies, serum anti-AAV8 antibodies) and enzyme-linked immunospot at assessed time points

    Immunogenicity measurements

    Measured: Wk 18, Wk 34, Wk 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start29 Dec 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 ABBV-RGX-314 treatment arms, 1 control arm (ranibizumab)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04704921
Sponsor's protocol ID
RGX-314-2104
Other IDs
M23-416
Acronym
ATMOSPHERE
Status last verified
Apr 2026
First submitted
8 Jan 2021
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ABBV-RGX-314 and Ranibizumab (LUCENTIS®) in people with AMD and nAMD, run by AbbVie at 89 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in Best Corrected Visual Acuity (BCVA) (time frame: At Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04704921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in