Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label IAI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Aflibercept Injection (IAI) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed. | Baseline to Week 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF) | Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data. | Baseline to Week 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES) | EES included all eligible patients who were treated in the study eye, untreated in the fellow eye, had baseline specular microscopy image in both eyes, and completed week 52 evaluation in both eyes and treatment with systemic anti-VEGF therapeutics |
Inclusion criteria include but are not limited to:
Exclusion criteria include but are not limited to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
Not provided
The study was conducted at 43 sites in the US from 14Nov2012 to 03Sep2015. The target study population consisted of men and women 50 years of age and older with neovascular AMD who met all study eligibility criteria. A total of 288 patients were screened, of whom 154 patients were enrolled and treated. A total of 126 patients completed week 100.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open Label IAI | 2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF) |
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed. |
| At week 52 and At week 100 |
| Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. | Baseline to Week 52 |
| Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. | Baseline to Week 100 |
| Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. | Baseline to Week 100 |
| At week 24 and At week 52 |
| Tucson |
| Arizona |
| United States |
| Beverly Hills | California | United States |
| Oakland | California | United States |
| Palm Desert | California | United States |
| Sacramento | California | United States |
| Santa Ana | California | United States |
| Westlake Village | California | United States |
| Colorado Springs | Colorado | United States |
| Golden | Colorado | United States |
| Boynton Beach | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Fort Myers | Florida | United States |
| Pensacola | Florida | United States |
| Plantation | Florida | United States |
| Tampa | Florida | United States |
| Winter Haven | Florida | United States |
| Augusta | Georgia | United States |
| Oak Park | Illinois | United States |
| New Albany | Indiana | United States |
| Wichita | Kansas | United States |
| Lexington | Kentucky | United States |
| Boston | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Jackson | Michigan | United States |
| Lincoln | Nebraska | United States |
| Las Vegas | Nevada | United States |
| Portsmouth | New Hampshire | United States |
| Bloomfield | New Jersey | United States |
| Lawrenceville | New Jersey | United States |
| Northfield | New Jersey | United States |
| Teaneck | New Jersey | United States |
| Rochester | New York | United States |
| Asheville | North Carolina | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Salem | Oregon | United States |
| Kingston | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Florence | South Carolina | United States |
| Ladson | South Carolina | United States |
| West Columbia | South Carolina | United States |
| Rapid City | South Dakota | United States |
| Nashville | Tennessee | United States |
| Arlington | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Seattle | Washington | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline analysis population was based on the safety analysis set (SAF) and included all patients who received at least 1 dose of study drug, regardless of the treatment for the study eye or the fellow eye.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open Label IAI | Intravitreal Aflibercept Injection (IAI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Best Corrected Visual Acuity (BCVA) in the study eye (Letters Read) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. | Mean | Standard Deviation | letters correctly read |
| ||||||||||||||||
| Central Subfield Thickness in the study eye by Optical Coherence Tomography (OCT) | Retinal and lesion characteristics (wet or dry) were evaluated using spectral domain OCT on the study eye and the fellow eye at every study visit. | Mean | Standard Deviation | micrometers (μm) |
| ||||||||||||||||
| Corneal Endothelial Cell Density - Endothelial Cell Density Evaluable Set (EES) | Central ECD of the corneal endothelium in the study eye and the fellow eye was evaluated by specular microscopy. | EES | Mean | Standard Deviation | cells/mm^2 |
|
| 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 | Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed. | Results are presented for the full analysis set (FAS). FAS included all patients who received at least one dose of study drug in the study eye, had baseline Best Corrected Visual Acuity (BCVA) assessment on the study eye, and had at least one post-baseline BCVA assessment on the study eye. | Posted | Mean | Standard Deviation | letters correctly read | Baseline to Week 100 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF) | Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data. | Full analysis set (FAS) | Posted | Number | percentage of participants | Baseline to Week 100 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed. | FAS | Posted | Number | percentage of participants | At week 52 and At week 100 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. | FAS | Posted | Mean | Standard Deviation | Letters correctly read | Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. | FAS | Posted | Number | percentage of participants | Baseline to Week 100 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. | FAS | Posted | Number | percentage of participants | Baseline to Week 100 |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES) | EES included all eligible patients who were treated in the study eye, untreated in the fellow eye, had baseline specular microscopy image in both eyes, and completed week 52 evaluation in both eyes and treatment with systemic anti-VEGF therapeutics | EES | Posted | Mean | Standard Deviation | percent change from baseline | At week 24 and At week 52 |
|
|
Adverse event data were collected during the period baseline to week 100
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label IAI | 2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96 | 45 | 154 | 38 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Transitional cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thromboangiitis obliterans | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Detachment of retinal pigment epithelium | Eye disorders | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Retinal haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Retinal pigment epithelial tear | Eye disorders | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Neovascular age-related macular degeneration | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Vitreous floaters | Eye disorders | MedDRA 18.0 | Non-systematic Assessment | Study eye |
|
| Bronchitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
After completion of the trial, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential or proprietary information from such communications. The sponsor cannot require other changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Administrator | Regeneron Pharmaceuticals, Inc. | clinicaltrials@regeneron.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| >=65 years |
|
| Fellow eye |
|
|
|
|
|
|
|
|