Trial Outcomes & Findings for Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy (NCT NCT02834663)
NCT ID: NCT02834663
Last Updated: 2020-05-22
Results Overview
BCVA was performed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at baseline and 6 months. The BCVA compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
COMPLETED
PHASE4
25 participants
6 months
2020-05-22
Participant Flow
This was an interventional, prospective, single-center study conducted at Wonkwang University Hospital from August 2016 to February 2019. All patients included in the study provided signed, informed consent prior to enrollment.
previous history of vitreoretinal surgery, post-cataract operation status (≤4 months before participation in this study), uncontrolled hypertension, or glaucoma were excluded from the study.
Unit of analysis: eyes
Participant milestones
| Measure |
Lucentis(Ranivizumab)
25 eyes of 25 type 2 diabetes mellitus patients with macular edema were included between August 2016 and February 2019. For 6 months, patients were administered 0.5-mg intra-vitreal Lucentis(Ranibizumab) injections monthly.
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|---|---|
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Overall Study
STARTED
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25 25
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Overall Study
COMPLETED
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25 25
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
Baseline Characteristics
n=25 Participants
Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study
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|---|---|
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Age, Continuous
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63.80 years
STANDARD_DEVIATION 11.45 • n=5 Participants
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Sex: Female, Male
Female
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12 Participants
n=5 Participants
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Sex: Female, Male
Male
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13 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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25 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Duration of Diabetes Mellitus(DM) (year)
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12.04 years
STANDARD_DEVIATION 7.475 • n=5 Participants
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HbA1c(%)
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8.27 %
STANDARD_DEVIATION 2.11 • n=5 Participants
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BCVA (ETDRS letters)
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67.60 ETDRS letters
STANDARD_DEVIATION 3.29 • n=5 Participants
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CRT (um)
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479.12 um
STANDARD_DEVIATION 16.66 • n=5 Participants
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Total microaneurysms (number)
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5.68 microaneurysms
STANDARD_DEVIATION 3.41 • n=5 Participants
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Microaneurysm-turnover
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6.88 microaneurysms/month
STANDARD_DEVIATION 3.83 • n=5 Participants
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Perifoveal non-perfused area (mm^2)
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2.517 mm^2
STANDARD_DEVIATION 0.456 • n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
BCVA was performed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at baseline and 6 months. The BCVA compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
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BCVA Resulte
n=25 Participants
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
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|---|---|---|
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The Best Corrected Visual Acuity (BCVA)
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67.6 letters
Standard Deviation 3.29
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76.36 letters
Standard Deviation 1.61
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PRIMARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
CRT was performed using OCT at each visit. The OCT measured at each visit was analyzed statistically. the CMT compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
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BCVA Resulte
n=25 Participants
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
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|---|---|---|
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Central Macular Thickness(CMT)
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479.12 um
Standard Deviation 16.66
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369.12 um
Standard Deviation 13.02
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
The number of MAs in individual retinas were evaluated during 6 months using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. Changes in MAs were analyzed statistically. the total number of MAs compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
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BCVA Resulte
n=25 Participants
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
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|---|---|---|
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The Total Number of Microaneurysm
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5.68 microaneurysms
Standard Deviation 3.41
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1.60 microaneurysms
Standard Deviation 1.73
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
number of new MAs detected/month The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month). The microaneurysm formation rate compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
|
BCVA Resulte
n=25 Participants
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
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|---|---|---|
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The Microaneurysm Formation Rate
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2.48 microaneurysms/month
Standard Deviation 1.98
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0.96 microaneurysms/month
Standard Deviation 1.02
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
Number of MAs that resolved/month The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month). The microaneurysm disappearance rate compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
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BCVA Resulte
n=25 Participants
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
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|---|---|---|
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The Microaneurysm Disappearance Rate
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4.40 microaneurysms/month
Standard Deviation 2.66
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0.96 microaneurysms/month
Standard Deviation 1.09
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
The microaneurysm formation rate + The microaneurysm disappearance rate The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month). The microaneurysm turnover compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
|
BCVA Resulte
n=25 Participants
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
|
|---|---|---|
|
The Microaneurysm Turnover
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6.88 microaneurysms/month
Standard Deviation 3.83
|
1.92 microaneurysms/month
Standard Deviation 1.75
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
Using ImageJ software (version 1.52a) by FAG image. The Perifoveal non-perfusion area in FAG compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
|
BCVA Resulte
n=25 Participants
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
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|---|---|---|
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Perifoveal Non-perfusion Area in FAG (mm²)
|
2.517 mm2
Standard Deviation 0.456
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2.495 mm2
Standard Deviation 0.293
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41-80 years) were included in the study.
Systemic adverse events (MI, CVA, etc), Ocular adverse events (retinal detachment, RPE tear, endophthalmitis, uveitis, vitreous hemorrhage, subretinal hemorrhage, cataract , IOP elevation, etc) at baseline and each visit.
Outcome measures
| Measure |
BCVA Baseline
n=25 Participants
Before the treatment regimen, assessment of BCVA using the ETDRS charts.
|
BCVA Resulte
After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.
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|---|---|---|
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Safety Parameters
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0 Participants
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—
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Adverse Events
Adverse Event
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place