Efficacy and Safety Study of ESBA1008 Versus EYLEA®
This trial is active, not recruiting.
|Condition||exudative age-related macular degeneration|
|Treatments||esba1008 solution, aflibercept|
|Start date||March 2013|
|End date||October 2013|
|Trial size||173 participants|
|Trial identifier||NCT01796964, C-12-006|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Change from Baseline in Visual Acuity at Week 12
time frame: Baseline, Week 12
Change from Baseline in Visual Acuity at Week 16
time frame: Baseline, Week 16
Change from Baseline in Visual Acuity, Up to Week 56
time frame: Baseline, Up to Week 56
Change from Baseline in Central Subfield (CSF) Thickness by Visit
time frame: Up to Week 56
Male or female participants at least 50 years old.
- 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.
- 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.
|Official title||A Prospective, Randomized, Double-Masked, Multicenter, Two Arm Study Comparing the Efficacy and Safety of ESBA1008 Versus EYLEA® in Subjects With Exudative Age-Related Macular Degeneration|
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