Diabetic Retinopathy, Macular Edema
Conditions
Keywords
Diabetic Macular Edema, Diabetic Retinal Swelling, DIabetic Eye Disease
Brief summary
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
Detailed description
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.
Interventions
DRUGRanibizumab
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Sponsors
Genentech, Inc.
Retina Vitreous Associates of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 18 years * Patient related considerations * Phakic or pseudophakic patients with a known history of diabetes will be eligible. * Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug. * Disease related considerations: * Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication. * Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40 * Central foveal thickness on SD-OCT of \>300um
Exclusion criteria
* Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous medical investigation or trial * Foveal ischemia on IVFA * Intraocular surgery less than 6 months ago * Epiretinal membrane of clinical significance * Prior vitrectomy * Uncontrolled glaucoma * Macular or peripheral laser within 90 Days from Day 0 injection * Intravitreal steroid injection within 90 days from Day 0 injection * Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. | Baseline through 24 months | The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Injections. | 24 months | The average number of intravitreal ranibizumab injections in each arm of the study will be recorded. |
| Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT). | 24 months | Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine. |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better. | 24 months | The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet. |
| Percentage of Patients Anatomically Dry. | 24 Months | Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with dry maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Monthly Ranibizumab Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. | 10 |
| Treat and Extend Ranibizumab Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically dry, at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treat and Extend Ranibizumab | Total | Monthly Ranibizumab |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Continuous | 60.4 years | 62.5 years | 64.5 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 1 / 10 |
| serious Total, serious adverse events | 3 / 10 | 1 / 10 |
Outcome results
Primary
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
Time frame: Baseline through 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monthly Ranibizumab | Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. | 8.3 ETDRS Letters | Standard Deviation 7.2 |
| Treat and Extend Ranibizumab | Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. | 8.5 ETDRS Letters | Standard Deviation 8.9 |
Secondary
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monthly Ranibizumab | Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT). | -169.0 microns | Standard Deviation 98.5 |
| Treat and Extend Ranibizumab | Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT). | -146.8 microns | Standard Deviation 122 |
Secondary
Mean Number of Injections.
The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monthly Ranibizumab | Mean Number of Injections. | 19.4 injections | Standard Deviation 5.9 |
| Treat and Extend Ranibizumab | Mean Number of Injections. | 18.8 injections | Standard Deviation 2.9 |
Secondary
Percentage of Patients Anatomically Dry.
Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with dry maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monthly Ranibizumab | Percentage of Patients Anatomically Dry. | 8 Participants |
| Treat and Extend Ranibizumab | Percentage of Patients Anatomically Dry. | 7 Participants |
Secondary
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monthly Ranibizumab | Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better. | 10 Participants |
| Treat and Extend Ranibizumab | Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better. | 9 Participants |