Phase 2
Completed N=89
Efficacy and Safety Study of ESBA1008 Versus EYLEA®
Exudative Age-Related Macular Degeneration
Source: ClinicalTrials.gov NCT01796964 ↗
Enrolled (actual)
89
Serious AEs
7.6%
Results posted
Feb 2016
Primary outcomePrimary: Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 — 54.1; 55.6; 5.8; 6.9 letters
Summary
The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 |
54.1; 55.6; 5.8; 6.9 | — |
| SECONDARY BCVA Change From Baseline (No. of Letters) to Week 16 |
54.1; 55.6; 6.0; 6.6 | — |
| SECONDARY BCVA Change From Baseline (No. of Letters) by Visit |
54.1; 55.6; 4.8; 4.3; 6.0; 6.5 | — |
| SECONDARY Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 |
54.1; 55.6; 5.7; 6.1; 6.2; 6.6 | — |
| SECONDARY Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56 |
59.8; 62.4; 1.1; 0.5; 1.1; -0.1 | — |
| SECONDARY One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month |
0.3; -0.2; -0.4; 0.9; -1.7; -0.1 | — |
| SECONDARY One-Month BCVA Changes (No. of Letters) Following Treatment by Visit |
1.5; 0.6; 1.2; -1.6; -0.5; -0.2 | — |
| SECONDARY Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group |
0.8; -1.3 | — |
| SECONDARY Central Subfield Thickness (CSFT) Change From Baseline by Visit |
490.1; 495.7; -184.7; -153.0; -198.5; -176.1 | — |
Eligibility Criteria
Inclusion Criteria
- Give written informed consent; be able to make the required study visits and follow instructions.
- Diagnosis of wet age-related macular degeneration, as specified in protocol.
- Best-corrected visual acuity (BCVA) as specified in protocol
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Either eye: Any active ocular or periocular infection or active intraocular inflammation.
- Study eye: Any approved or investigational treatment for exudative AMD other than vitamin supplements.
- Study eye: Any current or history of macular or retinal disease other than exudative AMD.
- Study eye: Any concurrent intraocular condition that, in the opinion of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat vision loss, or that limits the potential to gain visual acuity with the investigational product.
- Study eye: Uncontrolled glaucoma.
- Study eye: Any ocular disease that, in the opinion of the Investigator, could compromise the visual acuity.
- Study eye: History of eye surgery, as specified in protocol.
- Study eye: Use of corticosteroids, as specified in protocol.
- Any medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or safe administration of investigational product.
- Any screening laboratory result that, in the opinion of the Investigator, would make the patient unsuitable for study participation.
- History of hypersensitivity to any component used in the study, as assessed by the Investigator.
- Women of childbearing potential: Lactating, pregnant, plan to become pregnant, or not using adequate birth control, as specified in protocol.
- Participation in an investigational drug or device study within time period specified in protocol.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01796964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.