Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration

Study Overview
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Brief Summary
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The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.

Detailed Description
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The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.

Official Title
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Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD

Conditions
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Exudative Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: AL-78898A
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to give informed consent, make the required study visits and follow instructions; Newly diagnosed with exudative age-related macular degeneration (AMD); Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye); Best-corrected visual acuity (BCVA) in study eye as specified in protocol; No vision-threatening ocular condition other than AMD, in the opinion of the Investigator; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: History or current evidence of macular or retinal disease other than exudative AMD (study eye); Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye); Any evidence of vitreous hemorrhage (study eye); History or evidence of surgery (study eye), as specified in protocol; Any active systemic infection or ocular/intraocular infection or inflammation in either eye; A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol; History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator; Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study; Participation in any ocular or non-ocular investigational study within 30 days of screening; Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-78898A<br>Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up | Drug: AL-78898A<br>* Investigational treatment<br>|
| Active Comparator: Lucentis<br>Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up | Drug: Ranibizumab<br>* Anti-vascular endothelial growth factor (VEGF) treatment<br>* Other names: LUCENTIS®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4 | The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease. | Week 4 | 
| Incidence of Events of Special Interest (ESI) | An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand. | Up to Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet AMD, Intravitreal Injection, Macular Degeneration, VEGF treatment