Phase 2
N=194
ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
Exudative Age-Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01304693 ↗Enrolled (actual)
194
Serious AEs
8.8%
Results posted
May 2014
Primary outcome: Primary: Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT) — -142.3; -181.6; -175.6; -174.9 microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ESBA1008 solution (Biological); Ranibizumab 0.5 mg (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT) |
-142.3; -181.6; -175.6; -174.9; -159.4 | — |
| SECONDARY Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria |
45; 75; 67.5; 75; 45 | — |
Summary
The purpose of this study was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent.
- Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.
- New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.
- Evidence of subretinal fluid or retinal cystic changes with a CSFT of > 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.
- Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Previously administered therapy, approved or investigational, for wet AMD in the study eye.
- Any current or history of macular or retinal disease in the stuy eye other than wet AMD.
- Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.
- Uncontrolled or advanced glaucoma in the study eye.
- Use of systemic or topical ocular corticosteroids.
- History of a medical condition that, in the opinion of the Investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication.
- Abnormal or unsuitable laboratory results at Screening visit.
- Lactating or pregnant. Women of childbearing potential must use adequate birth control for the duration of the study.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01304693). 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.