Trial Outcomes & Findings for The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates (NCT NCT02448446)
NCT ID: NCT02448446
Last Updated: 2021-07-08
Results Overview
Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
6-12 months
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 Participants
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 Participants
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
15 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
9 Participants
n=24 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 8.46 • n=12 Participants
|
67 years
STANDARD_DEVIATION 8.83 • n=12 Participants
|
65.75 years
STANDARD_DEVIATION 8.65 • n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
14 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
10 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 6-12 monthsCompare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.
Outcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 Eyes
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 Eyes
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
6 Months
|
78 letters read correctly
Standard Deviation 9.98
|
73.92 letters read correctly
Standard Deviation 8.40
|
|
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
12 Months
|
77.92 letters read correctly
Standard Deviation 9.61
|
74.83 letters read correctly
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 eyes
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 eyes
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
|
70 percentage of eyes
|
83 percentage of eyes
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 eyes
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 eyes
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
|
60 percentage of eyes
|
58 percentage of eyes
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 eyes
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 eyes
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
|
7 eyes
|
7 eyes
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 eyes
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 eyes
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
|
90 percentage of eyes
|
92 percentage of eyes
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 Participants
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 Participants
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 eyes
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 eyes
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: eyes
Outcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 Participants
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 Participants
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: eyes
Outcome measures
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 Participants
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 Participants
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
|
9 Participants
|
9 Participants
|
Adverse Events
Diabetic Macular Edema Treatment Group (Group 1)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 participants at risk
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 participants at risk
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Gastrointestinal disorders
Cysticercosis
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Cardiac disorders
Low Hemoglobin
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Cardiac disorders
Congestive Heart Failure
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Infections and infestations
Kidney Infection
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Vascular disorders
Stroke
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Infections and infestations
Appendix Surgery
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 2 • 1 year
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Diabetic Macular Edema Treatment Group (Group 1)
n=12 participants at risk
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
ranibizumab 0.3mg: intravitreally administered
|
Diabetic Macular Edema and Lipid Treatment Group (Group 2)
n=12 participants at risk
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
ranibizumab 0.3mg: intravitreally administered
|
|---|---|---|
|
Ear and labyrinth disorders
Ear Infection
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Blood and lymphatic system disorders
Elevated Blood Pressure
|
8.3%
1/12 • Number of events 1 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • 1 year
|
25.0%
3/12 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Decreased Liver Function
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 2 • 1 year
|
|
Eye disorders
Branch Retinal Artery Occlusion
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Vascular disorders
Headache
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Immune system disorders
Shingles
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Blood and lymphatic system disorders
Elevated Triglycerides
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Eye disorders
Central Retinal Vein Occlusion
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Eye disorders
Ocular Hypertension
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Social circumstances
Broken Wrist
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Eye disorders
Allergic conjunctivitis
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Social circumstances
Right Hip Injury
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Product Issues
Drug Administration Error
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Eye disorders
Subconjunctival Hemhorrage
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Eye disorders
Visual Acuity Loss
|
8.3%
1/12 • Number of events 1 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Tumor
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Eye disorders
Floater
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place