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
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab alone | Active Comparator |
| |
| Combined group | Active Comparator | Bevacizumab plus Ozurdex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | intravitreal, 1.25mg., monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline | Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. | baseline to 12 month |
| OCT CST | change in optical coherence tomography central subfield thickness | change in OCT CST from baseline to twelve months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raj K Maturi, MD | Midwest Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raj K. Maturi, MD | Indianapolis | Indiana | 46290 | United States |
Subjects were randomly assigned to either bevacizumab alone or bevacizumab plus Ozurdex in a 1:1 ratio. When both eyes were eligible, the right eye was randomized and the left eye was assigned to the other group. We had a total of 30 subjects, 10 with both eyes. 19 eyes were in the Bevacizumab Alone group and 21 eyes were in the Combined Group.
The study was conducted at a single center. The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab Alone | monthly injection of bevacizumab intravitreally when retreatment criteria met |
| FG001 | Combined Group | bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The unit of "eyes" is used to described the number of participants since some subjects had both eyes in the study and it is not feasible to separate those into their own group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab Alone | Bevacizumab only |
| BG001 | Combine Group | Bevacizumab plus Ozurdex |
| 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 |
| 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 Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline | Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. | The unit of measure is EYES rather than actual number of participants | Posted | Mean | Standard Deviation | letters | baseline to 12 month |
|
1 year
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 | Bevacizumab Alone Group | bevacizumab 1.25mg intravitreally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute renal insufficiency | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headaches | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raj K. Maturi, MD | Raj K. Maturi, MD, PC | 317-817-1414 | rmaturi@gmail.com |
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| dexamethasone intravitreal implant | Drug | 0.7mg, intravitreal every 4 months |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study) | Number | eyes |
|
|
|
| Primary | OCT CST | change in optical coherence tomography central subfield thickness | Posted | Mean | Standard Deviation | microns | change in OCT CST from baseline to twelve months |
|
|
|
| 2 |
| 9 |
| 9 |
| 9 |
| EG001 | Combined Group | bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other. | 8 | 21 | 21 | 21 |
| cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| cerebrovascular accident | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| hyperkalemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| pancytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| generalized weakness | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of hypertension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| renal insufficiency | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| angina | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| blepharitis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| osteophyte right foot | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| canaliculitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| congestive heart failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| contusion left arm | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| corneal abrasion | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| corneal precipatates | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| cough | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| cyst lower eyelid | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| decreased ability to concentrate | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| decreased visual acuity | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| degenerative joint disease | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| ocular discomfort | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| dizziness | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| dry eye syndrome | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| otitis media | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| epiretinal membrane | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| esophageal candidiasis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| esophageal candidiasis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| fallen arch left foot | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| vitreous floater | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| peripheral edema | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| fracture ribs | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| adhesive capsulitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| suspected glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| hordeolum lower eyelid | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypothyroidism | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| increased intraocular pressure | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| infection of toe | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| iritis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| keratitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| knee pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| loss of blood sugar control | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| low back bain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| low tension glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| macular scar | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| magnesium deficiency | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| nail fungus | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| neovascularization of retina | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| peripheral vascular insufficiency | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| poison ivy | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| posterior capsule opacification | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| heel discomfort | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| laceration right leg | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| sciatica | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| sleep apnea | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| ankle sprain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| subconjunctival hemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| tear film insufficiency | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| foot ulcer | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| visual disturbance | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| vitreous hemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of cataract | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of diabetes mellitus | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of hypertension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of peripheral vascular disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of posterior capsule opacification | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of vitreoretinal traction | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| worsening of vitreous hemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |