Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03126786 | Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema | PHASE2 | COMPLETED | 71 | — | — | Jul 11, 2017 | Apr 17, 2018 | May 13, 2021 | 29 | United States |
| NCT02949024 | Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema | PHASE1 | COMPLETED | 20 | — | — | Nov 10, 2016 | Oct 17, 2017 | May 13, 2021 | 2 | United States |
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
| Arm | Type | Description |
|---|---|---|
| Active | ACTIVE_COMPARATOR | Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA |
| Control | SHAM_COMPARATOR | Treatment will consist of IVT aflibercept injection followed by a sham SC procedure |
| TX Naïve Arm | EXPERIMENTAL | Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye. |
| Previous TX Arm | EXPERIMENTAL | Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA. |
| Name | Type | Description |
|---|---|---|
| IVT aflibercept | DRUG | IVT aflibercept \[2 mg/0.05 mL\] |
| Sham SC | DRUG | sham SC |
| SC CLS-TA | DRUG | CLS-TA \[4 mg/100 μL\] SC injection |
Inclusion Criteria: * Clinical diagnosis of type 1 or type 2 DM * DME with central involvement (\> 300 µm in the central subfield on spectral-domain optical coherence tomography \[SD-OCT\], in the study eye * ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye * Naïve to lo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | — | ADVM-022 |