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
Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema (DME).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly Intravitreal ranibizumab 0.3mg | Active Comparator | Monthly Intravitreal ranibizumab 0.3mg injections. |
|
| PRN Intravitreal ranibizumab 0.3mg | Active Comparator | PRN Intravitreal ranibizumab 0.3mg injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal ranibizumab 0.3mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| A Change Between Two Time Points is Reported for Maximum Reading Speed | A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activity Productivity | To evaluate the mean change in activity impairment from baseline to 12 months using and activity impairment questionnaire. Scale is from 0-10 with 0 being lowest (no effect on my daily activities) and 10 being highest (completely prevented me from doing my daily activities). | Month 12 |
Not provided
Inclusion Criteria:
Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age 18 ≤ x ≤ 65 years and currently employed at the baseline study visit
Diagnosis of diabetes mellitus (type 1 or 2)
o Any one of the following will be considered to be sufficient evidence that diabetes is present:
Current regular use of insulin for treatment of diabetes
Current regular use of oral anti-hyperglycemia agent for the treatment of diabetes
Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
Central diabetic macular edema present on clinical examination or or evidence indicating disease activity on spectral domain OCT.
Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Gordon, PhD | California Retina Consultants | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants - Bakersfield | Bakersfield | California | 93039 | United States | ||
| California Retina Consultants |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Monthly | Monthly Intravitreal ranibizumab 0.3mg |
| FG001 | PRN Group | PRN Intravitreal ranibizumab 0.3mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in Visual Acuity |
To determine the mean change in best-corrected visual acuity on ETDRS visual acuity chart at a starting distance of 4 meters from baseline. 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. |
| Month 12 |
| Change in Contrast Sensitivity | To measure the mean change in contrast sensitivity scores on Pelli-Robson charts from baseline. Scale in assessing the log of the contract sensitivity score (CS score) is from 0-2.25, with 0 being no letters read on the contrast sensitivity chart, and 2.25 being all letters read on the contrast sensitivity chart. Total CS score = [(total # letters correct - 3) x 0.05]. | 12 months |
| Oxnard |
| California |
| 93454 |
| United States |
| California Retina Consultants | Palmdale | California | 93551 | United States |
| California Retina Consultants - Santa Barbara Office | Santa Barbara | California | 93103 | United States |
| California Retina Consultants | Santa Maria | California | 93454 | United States |
| California Retina Consultants | Visalia | California | 93277 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Monthly | Monthly Intravitreal ranibizumab 0.3mg |
| BG001 | PRN Group | PRN Intravitreal ranibizumab 0.3mg |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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 | A Change Between Two Time Points is Reported for Maximum Reading Speed | A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed. | MNREAD words per minute | Posted | Mean | Standard Deviation | words per minute | Month 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change in Activity Productivity | To evaluate the mean change in activity impairment from baseline to 12 months using and activity impairment questionnaire. Scale is from 0-10 with 0 being lowest (no effect on my daily activities) and 10 being highest (completely prevented me from doing my daily activities). | Posted | Mean | Standard Deviation | Units on a scale | Month 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Visual Acuity | To determine the mean change in best-corrected visual acuity on ETDRS visual acuity chart at a starting distance of 4 meters from baseline. 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. | Posted | Mean | Standard Deviation | Letters | Month 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Contrast Sensitivity | To measure the mean change in contrast sensitivity scores on Pelli-Robson charts from baseline. Scale in assessing the log of the contract sensitivity score (CS score) is from 0-2.25, with 0 being no letters read on the contrast sensitivity chart, and 2.25 being all letters read on the contrast sensitivity chart. Total CS score = [(total # letters correct - 3) x 0.05]. | Posted | Mean | Standard Deviation | Units on a scale | 12 months |
|
|
Through study completion, an average of 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 | Monthly | Monthly Intravitreal ranibizumab 0.3mg | 0 | 20 | 5 | 20 | 15 | 20 |
| EG001 | PRN Group | PRN Intravitreal ranibizumab 0.3mg | 1 | 20 | 4 | 20 | 8 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| fractured humerus and tibia | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Septic Knee | Infections and infestations | Non-systematic Assessment |
| ||
| stress, cardiomyopathy, acute renal disfunction | Cardiac disorders | Non-systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| lower back and abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| congestive heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Urinary Tract Infection with Sepsis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Flu/cold | Infections and infestations | Systematic Assessment |
| ||
| Eye Pain | Eye disorders | Systematic Assessment |
| ||
| Eye redness | Eye disorders | Systematic Assessment |
| ||
| Eye Itchiness (ocular pruitis) | Eye disorders | Systematic Assessment |
| ||
| Blurry/distorted vision | Eye disorders | Systematic Assessment |
| ||
| Allergies/ Congestion | Immune system disorders | Systematic Assessment |
| ||
| Shingles | Infections and infestations | Systematic Assessment |
| ||
| Floaters | Eye disorders | Systematic Assessment |
| ||
| Photophobia | Eye disorders | Systematic Assessment |
| ||
| Selective Laser Trabeculotomy | Surgical and medical procedures | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anxiety | General disorders | Systematic Assessment |
| ||
| Insomnia | General disorders | Systematic Assessment |
| ||
| fall | General disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| leg injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| herniea/hernia repair | Surgical and medical procedures | Systematic Assessment |
| ||
| Cataract Extraction | Surgical and medical procedures | Systematic Assessment |
| ||
| Subconjunctival Hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Heart Infection | Infections and infestations | Systematic Assessment |
| ||
| Food Poisoning | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hospitalization for swelling and fluid | General disorders | Systematic Assessment |
| ||
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | California Retina Consultants | 8059631648 | gabe@californiaretina.com |
| Oct 4, 2018 |
| Prot_SAP_000.pdf |
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
|