Diabetic Macular Edema
Conditions
Brief summary
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).
Interventions
DRUGIntravitreal ranibizumab 0.3mg
Sponsors
California Retina Consultants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception. * Participation in another ocular investigation or trial simultaneously * Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110) * Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse) * Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema * An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy) * Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas) * Evidence of active neovascularization of the iris or retina * Evidence of central atrophy or fibrosis in the study eye * Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study. * Previous use of intraocular or periocular corticosteroids in the study eye in the previous 120 days * Previous treatment with anti-angiogenic drugs in the study eye i.e. pegaptanib sodium, bevacizumab, ranibizumab, aflibercept within 120 days prior to baseline * History of vitreous surgery in the study eye * History of cataract surgery within 3 months of enrollment. * History of YAG capsulotomy within 2 months of enrollment. * Visual acuity \<20/400 in the fellow eye * Uncontrolled glaucoma (pressure \>30) despite treatment with glaucoma medications. * History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Change Between Two Time Points is Reported for Maximum Reading Speed | Month 12 | A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activity Productivity | Month 12 | 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). |
| Change in Visual Acuity | Month 12 | 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. |
| Change in Contrast Sensitivity | 12 months | 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 = \[(total # letters correct - 3) x 0.05\]. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Monthly Monthly Intravitreal ranibizumab 0.3mg | 20 |
| PRN Group PRN Intravitreal ranibizumab 0.3mg | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | mental instability | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Monthly | PRN Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 1 / 20 |
| other Total, other adverse events | 15 / 20 | 8 / 20 |
| serious Total, serious adverse events | 5 / 20 | 4 / 20 |
Outcome results
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.
Time frame: Month 12
Population: MNREAD words per minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monthly | A Change Between Two Time Points is Reported for Maximum Reading Speed | 161.94 words per minute | Standard Deviation 43.56 |
| PRN Group | A Change Between Two Time Points is Reported for Maximum Reading Speed | 167.65 words per minute | Standard Deviation 32.3 |
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).
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monthly | Change in Activity Productivity | -2.25 Units on a scale | Standard Deviation 3.14 |
| PRN Group | Change in Activity Productivity | -0.78 Units on a scale | Standard Deviation 2.44 |
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 = \[(total # letters correct - 3) x 0.05\].
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monthly | Change in Contrast Sensitivity | 0.39 Units on a scale | Standard Deviation 0.45 |
| PRN Group | Change in Contrast Sensitivity | 0.26 Units on a scale | Standard Deviation 0.4 |
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.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monthly | Change in Visual Acuity | 17.42 Letters | Standard Deviation 15.13 |
| PRN Group | Change in Visual Acuity | 14.92 Letters | Standard Deviation 11.6 |