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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-78898A | Experimental | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
|
| Lucentis | Active Comparator | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-78898A | Drug | Investigational treatment |
| |
| Ranibizumab |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehdi Hosseini | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 99 subjects enrolled, 48 were considered screen failures and were exited from the study prior to randomization. Of the 51 subjects randomized, 2 did not receive treatment. This reporting group includes all randomized subjects who received study medication.
Subjects were recruited from 14 study centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AL-78898A | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| FG001 | Lucentis | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all randomized subjects who received study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | AL-78898A | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| BG001 | Lucentis | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients who received study medication, completed at least one scheduled post-injection study visit, and did not receive standard therapy prior to Week 4 assessment | Posted | Mean | Standard Deviation | microns | Week 4 |
|
Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication.
An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AL-78898A | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment | Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehdi Hosseini, Clinical Trial Manager | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Anti-vascular endothelial growth factor (VEGF) treatment |
|
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Lucentis | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
|
|
| Primary | 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. | Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit | Posted | Number | events | Up to Day 30 |
|
|
|
| 5 |
| 38 |
| 14 |
| 38 |
| EG001 | Lucentis | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up | 1 | 11 | 5 | 11 |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment | Not related |
|
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment | Not related |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment | Not related |
|
| Death | General disorders | MedDRA 14.0 | Systematic Assessment | Not related |
|
| Eye irritation | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Retinal pigment epithelial tear | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eye pruritis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lens disorder | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Open angle glaucoma | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |