NCT05891548CompletedPhase 2
Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration
ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 25 Jul 2025
Brief summary (registry, in English)
Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 24 May 2023
- Start date
- 31 May 2023
- Primary completion date
- 20 Aug 2024
- Lead sponsor
- Clearside Biomedical, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT05891548
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 31 May 2023 to the primary completion date, 20 Aug 2024
- 32 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subretinal hemorrhage, fibrosis or atrophy of \>50% of the total lesion area and/or that involves the fovea on fundus fluorescein angiography and/or color fundus photography in the study eye.
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye.
Other
- ETDRS BCVA \<20 letters in the study eye.
- Central subfield thickness \> 400 μm or retinal pigment epithelium detachment thickness \>400 μm on SD-OCT in the study eye.
- CNV due to causes other than AMD, such are ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis, in the study eye.
Who the study is looking for
- Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eye within 36 months of Visit 1.
- Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type in the study eye that shows total lesion area ≤30 mm2, CNV component area of ≥50% of the total lesion area, and and CNV must not be associated with subfoveal hemorrhage, subfoveal fibrosis, or subfoveal atrophy.
- Previous treatment in the study eye with between 2 and 4 anti-VEGF intravitreal injections for nAMD (faricimab, ranibizumab, bevacizumab, brolucizumab, or aflibercept) per standard of care within 6 months of Visit 1.
- History of response to prior intravitreal anti-VEGF treatment in the study eye.
- ETDRS BCVA of between 20 and 80 letters (inclusive) in the study eye.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Research Institute of Texas Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| Texas Retina Associates - Arlington Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Western Carolina Retinal Associates P.A. Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Southeast Retina Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Austin Retina Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Retina Consultants of Texas-Bellairre Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Envision Ocular, LLC Coordinator of this site? Confirm its status | Bloomfield | United States | Unknown status |
| Texas Retina Associates - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Wolfe Eye Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Retina Group of Washington Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Retina Group of Florida Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Retina Consultants of Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Retina Consultants of Texas - Katy Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Florida Retina Consultants Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| Georgia Retina PC Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Northern California Retina Vitreous Associates Medical Group INC. Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Tennessee Retina, PC Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Illinois Retina Associates Coordinator of this site? Confirm its status | Oak Park | United States | Unknown status |
| Retina Specialty Institute Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Retinal Research Institute, LLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Associated Retina Consultants Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Texas Retina Associates (Plano) Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Retina Consultants San Diego Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Retinal Consultants of Southern California Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Retinal Consultants Medical Group, Inc. Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retina Consultants of Texas: San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Spokane Eye Clinical Research Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Retina Associates of Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Vitreo-Retinal Associates, PC Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.