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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.
The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex | Experimental | Subjects will receive Ozurdex injections and will be monitored for macular edema. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex | Drug | Ozurdex .7 mg injected into the treated eye |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Retinal Thickness | At 3 months, central retinal thickness as measured by optical coherence tomography will be measured | 3 months |
| Visual Acuity | ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning. | 3 months |
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Inclusion Criteria:
Patients who are undergoing pars plana vitrectomy for:
Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)
Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.
Age between 18-85 years old
Exclusion Criteria:
Age < 18 years or > 85 years
History of macular edema due to diseases other than those in the inclusion criteria in the study eye
Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)
Patients who are cognitively impaired or those who are unable to provide informed written consent
Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded).
Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks).
Patients with recent periocular steroid injection (within past 4 weeks) in the study eye
Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Srivastava, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cole Eye Institute, Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozurdex | Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozurdex | Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye |
| 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 | Central Retinal Thickness | At 3 months, central retinal thickness as measured by optical coherence tomography will be measured | Optical Coherence Tomography was collected at 3 months. 22 of the patients were seen at month 3. | Posted | Median | Full Range | micrometers | 3 months |
|
|
Adverse events were collected from point of screening until their last visit at 12 months.
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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 | Ozurdex | Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent Corneal Epithelial Defect | Eye disorders | Systematic Assessment | Patient had a persistent corneal defect after vitrectomy surgery and implantation of Ozurdex. Subsequently healed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in cataract surgical eye | Eye disorders | Systematic Assessment | Increase in cataract in the surgical eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sunil K. Srivastava, MD | Cleveland Clinic Foundation | 216-636-2286 | srivass2@ccf.org |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D003920 | Diabetes Mellitus |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Participants |
| No |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
| Primary | Visual Acuity | ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning. | 23 of the participants were able to come in for their 3 month appointment per protocol | Posted | Median | Full Range | ETDRS | 3 months |
|
|
|
| 0 |
| 30 |
| 7 |
| 30 |
| 27 |
| 30 |
|
| Area of tractional retinal detachment versus retinoschisis surgery eye | Eye disorders | Systematic Assessment | Patient had an are of possible tractional retinal detachment versus retinoschisis noted throughout the surgery after vitrectomy surgery. |
|
| Peptic ulcers-hospitalized for stomach pain | Gastrointestinal disorders | Systematic Assessment | Patient had a bout of stomach and was hospitalized and diagnosed with peptic ulcers. |
|
| Root canal infection | Infections and infestations | Systematic Assessment | Patient had a root canal and developed an infection afterwards |
|
| Removal of basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Patient had a biopsy of the nose that was subsequently diagnosed as a basal cell carcinoma |
|
| Ozurdex placment on fovea | Eye disorders | Systematic Assessment | After placement of Ozurdex it adhered to the fovea, requiring a second surgery where it went back into the normal position. |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment | Patient subsequently underwent a CABG procedure, had a previous history of cardiac issues. |
|
|
| Increase in cataract fellow eye | Eye disorders | Systematic Assessment | Increase in cataract surgery fellow eye |
|
| Increase in intraocular pressure | Eye disorders | Systematic Assessment | Increase in intraocular pressure |
|
| Worsening of diabetic disease fellow eye | Eye disorders | Systematic Assessment | Worsening of diabetic eye disease or cystoid macular edema |
|
| Motor vehicle accident | Injury, poisoning and procedural complications | Systematic Assessment | Patient was involved motor vehicle collusion no hospitalizations |
|
| worsening of posterior capsular opacity | Eye disorders | Systematic Assessment | Worsening of posterior capsular opacity study eye |
|
| worsening of posterior capsular opacity fellow eye | Eye disorders | Systematic Assessment | As described above |
|
| respiratory flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory flu |
|
| Dental infection | Infections and infestations | Systematic Assessment | Infection after dental procedure |
|
| Poison Ivy rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Was treated in the emergency room for poison ivy. |
|
| Tachycardia | Cardiac disorders | Systematic Assessment | found during a sleep study during a cardiology visit. |
|
| broken patella | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bronchitis | Reproductive system and breast disorders | Systematic Assessment |
|
| increased cystoid macular edema study eye | Eye disorders | Systematic Assessment |
|
| Transient Ischemic Avent | Nervous system disorders | Systematic Assessment | Patient had history of previous TIAs |
|
| Epithelial defect study eye | Eye disorders | Systematic Assessment | Patient had reported epithelial defect after vitrectomy surgery. |
|
| Increased itching both eyes | Eye disorders | Systematic Assessment |
|
| Increase in pain study eye | Eye disorders | Systematic Assessment | Patient noted increased pain in surgical eye |
|
| Increased diabetic retinopathy study eye | Eye disorders | Systematic Assessment |
|
| Increase of dryness of the eyes | Eye disorders | Systematic Assessment |
|
| Trouble breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | patient was diagnosed with pneumonia |
|
| Cartoid blockage | Cardiac disorders | Systematic Assessment | Patient had previous history of blockage was scheduled for outpatient stent |
|
| loss of vision fellow eye | Eye disorders | Systematic Assessment | Patient reported decrease vision fellow eye |
|
| small choroidal study eye | Eye disorders | Systematic Assessment | Choroidal was found postoperatively from vitrectomy surgery. |
|
| Vitreous hemorrhage study eye | Eye disorders | Systematic Assessment | Patient had a vitreous hemorrhage of study eye |
|
| Syncope after injection | General disorders | Systematic Assessment | patient had syncope episode after protocol injection of ozurdex |
|
| Trouble reading | Eye disorders | Systematic Assessment | Patient reported difficulty with reading both eyes |
|
| Nausea, vomiting diarrhea,dehydration | Injury, poisoning and procedural complications | Systematic Assessment | Went to the emergency room the night of surgery with complications of anesthesia from vitrectomy surgery- was not admitted |
|
| Worsening of Parkinson's tremors | Nervous system disorders | Systematic Assessment | Patient had past medical history of Parkinson's |
|
| Sarcoidosis Flare | Immune system disorders | Systematic Assessment | Patient had a flare of previously diagnosed sarcoidosis |
|
| Foreign body sensation of eyes | Eye disorders | Systematic Assessment | Patient reported feeling like something was in their eyes and irritating it- nothing was found in their eyes. |
|
| Injury to hip an back | Injury, poisoning and procedural complications | Systematic Assessment | Patient had a work related injury requiring physical therapy |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Patient reported diarrhea, did not seek medical attention |
|
| Subconjunctival hemorrhage fellow eye | Eye disorders | Systematic Assessment |
|
| Digestion issues | Gastrointestinal disorders | Systematic Assessment | Patient had reported digestion issue later diagnosed with GERD |
|
| Sinus infection | Infections and infestations | Systematic Assessment | Reported sinus infections |
|
| Increased floaters fellow eye | Eye disorders | Systematic Assessment |
|
| Decreased television vision fellow eye | Eye disorders | Systematic Assessment |
|
| Glare with vision at night | Eye disorders | Systematic Assessment |
|
| Tearing in both eyes | Eye disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |