Retina Consultants San Diego Opens Enrollment in Wet AMD Study With Clearside Biomedical
Retina Consultants San Diego (RCSD) has been selected to participate in a wet AMD study in collaboration with Clearside Biomedical. RCSD is one of the only San Diego-based sites to participate in the study.
ODYSSEY, a randomized, double-masked, parallel-group, active-controlled, multi-center Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) using suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD).
CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity.
About the ODYSSEY Phase 2b Clinical Trial
Number of Participants: 60 total participants with 2:1 randomization.
- 40 participants in CLS-AX arm and 20 participants in aflibercept arm.
Key inclusion criteria:
- Diagnosed with wet AMD within 36 months of screening.
- History of 2 to 4 anti-VEGF treatments in the 6 months before screening.
- History of response to anti-VEGF treatment for wet AMD.
- Reading center confirmation of persistent active disease.
- Best corrected visual acuity (BCVA) of 20 to 80 letters
Loading Doses: Participants in both arms will receive 3 aflibercept (2 mg) loading doses. In the CLS-AX arm, participants will receive one dose of CLS-AX (1.0 mg) at the same visit as the second loading dose of aflibercept (Baseline).
- In the CLS-AX arm, following the 3 loading doses of aflibercept and the initial dose of CLS-AX at Baseline, participants will receive CLS-AX at least every 24 weeks unless more frequently required based on disease activity.
- In the aflibercept arm, following the 3 loading doses, participants will receive aflibercept on a fixed dosing regimen every 8 weeks.
Monthly disease activity assessments: Will be conducted in both arms at Weeks 12 through 32 to determine if there is a need for supplemental treatment.
Supplemental treatment criteria (based on measurement changes due to wet AMD):
- BCVA reduction of >10 letters from Baseline.
- Increase in central subfield thickness (CST) of >100 microns on SD-OCT from Baseline.
- BCVA reduction of > 5 letters from Baseline AND increase in CST of >75 microns on SD-OCT from Baseline.
- Presence of new or worsening vision-threatening hemorrhage.
Primary outcome measure: Mean change in BCVA from Baseline to Week 36.
Secondary outcome measures:
- Other changes in visual function and ocular anatomy, such as CST.
- Need for supplemental treatment.
- Treatment burden as measured by total injections over trial duration.
Clearside Biomedical (Alpharetta, GA)
A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-Related Macular Degeneration
To learn more about clinical trials, including whether you are a good candidate for an ongoing clinical trial, please contact our Senior Clinical Research Manager, Max Briles, directly at [email protected] or by phone at 858-451-1911.