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
Not provided
Not provided
This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, 2, I 0.2 µg/Day + Sham | Experimental | 0.2 µg/Day |
|
| A, 2, II 0.5 µg/Day + Sham | Experimental | 0.5 µg/Day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinolone Acetonide | Drug | 0.2 µg/Day in study eye + Sham in fellow eye |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Size of Geographic Atrophy | 24 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kresge Eye Institute | Detroit | Michigan | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A, 2, I 0.2 µg/Day + Sham | 0.2 µg/Day Fluocinolone Acetonide: 0.2 µg/Day |
| FG001 | A, 2, II 0.5 µg/Day + Sham | 0.5 µg/Day Fluocinolone Acetonide: 0.5 µg/Day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients received either the 0.2µ/day or 0.5µ /day dose as well as a sham injection in the fellow eye. The total number of subjects enrolled/analyzed was 17.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A, 2, I 0.2 µg/Day + Sham | 0.2 µg/Day Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye |
| BG001 | A, 2, II 0.5 µg/Day + Sham | 0.5 µg/Day Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 From Baseline in Size of Geographic Atrophy | Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye. | Posted | Mean | Standard Deviation | mm3/year | 24 months |
|
Not provided
Each patient received a sham injection in one eye and active treatment in the other eye.
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 | Sham Injection | Sham Injection Sham Injection: Sham injection Ocular AEs |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Billman, Senior Director, Scientific Affairs | Alimera Sciences, Inc. | 678-527-1302 | kathleen.billman@alimerasciences.com |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluocinolone Acetonide |
| Drug |
0.5 µg/Day in study eye +Sham in fellow eye |
|
| Death |
|
| Study Terminated |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
0.5 µg/Day Fluocinolone Acetonide: 0.5 µg/Day |
|
|
| 3 |
| 17 |
| 10 |
| 17 |
| EG001 | 0.2 ug/Day | 0.2 µg/Day Fluocinolone Acetonide: 0.2 µg/Day Ocular AEs | 3 | 10 | 8 | 10 |
| EG002 | 0.5 ug/Day | 0.5 µg/Day Fluocinolone Acetonide: 0.5 µg/Day Ocular AEs | 2 | 7 | 7 | 7 |
| EG003 | 0.2 ug/Day + Sham Injection | Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection Systemic AEs | 3 | 10 | 5 | 10 |
| EG004 | 0.5 ug/Day + Sham Injection | Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection Systemic AEs | 5 | 7 | 6 | 7 |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Renal mass | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| Cataract subcapsular | Eye disorders | MedDRA | Systematic Assessment |
|
| Choroidal neovascularisation | Eye disorders | MedDRA | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA | Systematic Assessment |
|
| Myodesopsia | Eye disorders | MedDRA | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal pigment epithelial tear | Eye disorders | MedDRA | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cutis laxa | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |