Trial Outcomes & Findings for Safety and Efficacy of Ranibizumab for Diabetic Macular Edema (NCT NCT01982435)
NCT ID: NCT01982435
Last Updated: 2020-11-03
Results Overview
As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
12 months
Results posted on
2020-11-03
Participant Flow
Participant milestones
| Measure |
Group I - Monthly
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group I - Monthly
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Ranibizumab for Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients who exited the study early were accounted by using a last observation carried forward approach.
As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Number of Participants With Non-severe Ocular Adverse Events
Blurry Vision
|
9 Participants
|
5 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Elevated IOP
|
4 Participants
|
3 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Flashes
|
3 Participants
|
3 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Vitreous Floaters
|
3 Participants
|
2 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Dry eyes
|
3 Participants
|
2 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Redness
|
1 Participants
|
2 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Pruritus
|
2 Participants
|
0 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Tearing
|
1 Participants
|
1 Participants
|
|
Number of Participants With Non-severe Ocular Adverse Events
Non-severe ocular adverse events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAs identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Number of Participants With Severe Ocular Adverse Events
Endophthalmitis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Severe Ocular Adverse Events
Retinal Detachment
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAs identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Cardiac adverse event
|
8 Participants
|
4 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Blood and lymphatic adverse event
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Gastrointestinal adverse event
|
6 Participants
|
1 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
General adverse event
|
14 Participants
|
12 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Infectious advsere event
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Metabolic adverse event
|
3 Participants
|
2 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Musculoskeletal adverse event
|
12 Participants
|
8 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Cyst, polyp and tumor adverse event
|
3 Participants
|
0 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Nervous system adverse event
|
2 Participants
|
0 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Psychiatric adverse event
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Renal and urinary adverse event
|
5 Participants
|
3 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Reproductive adverse event
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Respiratory adverse event
|
1 Participants
|
5 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Skin and subcutaneous adverse event
|
8 Participants
|
2 Participants
|
|
Number of Participants With Non-severe Non-ocular Adverse Event
Vascular adverse event
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAs identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Number of Participants With Severe Non-ocular Adverse Event
TIA
|
1 Participants
|
0 Participants
|
|
Number of Participants With Severe Non-ocular Adverse Event
Hospitalizations
|
6 Participants
|
3 Participants
|
|
Number of Participants With Severe Non-ocular Adverse Event
Stroke
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Mean Change in BCVA
Month 6
|
.7 ETDRS letters
Standard Deviation 8.1
|
.7 ETDRS letters
Standard Deviation 8.1
|
|
Mean Change in BCVA
Month 12
|
2.1 ETDRS letters
Standard Deviation 8.3
|
7.4 ETDRS letters
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Months 6 and 12Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield)
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Mean Change in Central Foveal Thickness
Month 6
|
-28.8 microns
Standard Deviation 173.4
|
104.1 microns
Standard Deviation 165.6
|
|
Mean Change in Central Foveal Thickness
Month 12
|
-80.9 microns
Standard Deviation 184.7
|
-124 microns
Standard Deviation 157.6
|
SECONDARY outcome
Timeframe: Months 6 and 12Number of participants with an anatomically "dry" study eye by SDOCT at months 6 and 12
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Anatomically Dry Eyes by SDOCT
Month 6
|
0 Participants
|
0 Participants
|
|
Anatomically Dry Eyes by SDOCT
Month 12
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Gain in Vision Greater Than or Equal to 15 Letters
Month 6
|
0 Participants
|
2 Participants
|
|
Gain in Vision Greater Than or Equal to 15 Letters
Month 12
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Loss in Vision Greater Than or Equal to 15 Letters
Month 6
|
1 Participants
|
0 Participants
|
|
Loss in Vision Greater Than or Equal to 15 Letters
Month 12
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12.
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Participants With BCVA at 20/40 or Better
Month 6
|
1 Participants
|
2 Participants
|
|
Participants With BCVA at 20/40 or Better
Month 12
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3, 6 and 12 monthsNumber of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage).
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Number of Participants With Angiographic Leakage
3 month
|
15 Participants
|
12 Participants
|
|
Number of Participants With Angiographic Leakage
6 month
|
15 Participants
|
12 Participants
|
|
Number of Participants With Angiographic Leakage
12 month
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3, 6 and 12 monthsNumber of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia).
Outcome measures
| Measure |
Group I - Monthly
n=15 Participants
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 Participants
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Number of Participants With Nonperfusion
12 months
|
12 Participants
|
9 Participants
|
|
Number of Participants With Nonperfusion
3 months
|
13 Participants
|
9 Participants
|
|
Number of Participants With Nonperfusion
6 months
|
13 Participants
|
10 Participants
|
Adverse Events
Group I - Monthly
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Group II - Treat-and-Extend
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I - Monthly
n=15 participants at risk
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 participants at risk
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Renal and urinary disorders
Worsening of Chronic Kidney Disease
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
POSSIBLE CELLULITIS TO RIGHT LOWER EXTREMITY
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
TRANSIENT ISCHEMIC ATTACK
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
ACUTE INFARCT STROKE
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
UNSTABLE ANGINA AND CHEST PAIN
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
VERTIGO
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Reproductive system and breast disorders
LARGE OVARIAN NEOPLASM
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
HOSPITALIZED FOR PERITONITIS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
HOSPITALIZED FOR ANGINA/SOB
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
HOSPITALIZED FOR DIABETIC RIGHT HEEL ULCER
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Social circumstances
HOSPITALIZED FORCONFUSION/SLURRED SPEECH AFTER FALL
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
HOSPITALIZED FOR RECURRENT SOB, LEG EDEMA
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
HOSPITALIZATION FOR GANGRENE
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
HOSPITALIZATION R DIABETIC FOOT ULCER INFECTION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Reproductive system and breast disorders
HOSPITALIZATION FOR TOTAL HYSTERECTOMY
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Endocrine disorders
HOSPITALIZATION FOR HYPERKALEMIA
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
HOSPITALIZATION FOR GANGRENE/AMPUTATION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
HOSPITALIZATION FOR OSTEOMYELITIS/AMPUTATION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
Group I - Monthly
n=15 participants at risk
Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
|
Group II - Treat-and-Extend
n=12 participants at risk
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
|
|---|---|---|
|
Eye disorders
Decreased Vision
|
33.3%
5/15 • Number of events 5
|
33.3%
4/12 • Number of events 4
|
|
Cardiac disorders
Hypertension
|
26.7%
4/15 • Number of events 4
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Flu-like symptoms
|
26.7%
4/15 • Number of events 4
|
41.7%
5/12 • Number of events 5
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Difficulty with reading
|
33.3%
5/15 • Number of events 5
|
41.7%
5/12 • Number of events 5
|
|
General disorders
Difficulty with driving
|
13.3%
2/15 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Hyperglycemic episode
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Edema
|
20.0%
3/15 • Number of events 3
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Number of events 3
|
0.00%
0/12
|
|
Renal and urinary disorders
Worsening of diabetes
|
20.0%
3/15 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
13.3%
2/15 • Number of events 2
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Weight gain
|
6.7%
1/15 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Foreign Body Sensation
|
13.3%
2/15 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Hypoglycemic episode
|
13.3%
2/15 • Number of events 2
|
25.0%
3/12 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
26.7%
4/15 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Stye
|
20.0%
3/15 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Diplopia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Urinary Tract infection
|
13.3%
2/15 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain from fall
|
6.7%
1/15 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
Cardiac disorders
Chest pain
|
13.3%
2/15 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Generalized rash
|
20.0%
3/15 • Number of events 3
|
0.00%
0/12
|
|
General disorders
Headache
|
13.3%
2/15 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Thyroid cancer
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Uterine cancer suspect
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Bladder cancer
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
Eye disorders
Epiretinal Membrane
|
0.00%
0/15
|
25.0%
3/12 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/15
|
41.7%
5/12 • Number of events 5
|
|
Metabolism and nutrition disorders
Vitamin Deficiency
|
13.3%
2/15 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Elevated microalbumin
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Ocular irritation
|
40.0%
6/15 • Number of events 6
|
16.7%
2/12 • Number of events 2
|
|
Eye disorders
Eye Discharge
|
6.7%
1/15 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Generalized weakness
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomitting
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Anemia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign polyps
|
13.3%
2/15 • Number of events 2
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Thalassemia Trait
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Optic neuropathy
|
6.7%
1/15 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Atherosclerosis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Elevated Creatinine levels
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sun damage
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Elevated d-Dimer
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Hypomagnesemia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Ascites
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid nodule
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
OSA Worsening
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Nausea
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Worsening of cataracts
|
13.3%
2/15 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Cold Sore
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Hyperlipidemia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Glare in vision
|
13.3%
2/15 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Elevated INR
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pruritus after fluorescein dye
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Asymptomatic Bradycardia
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
6.7%
1/15 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Bullous eruption on glans
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus on neck
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Insomnia - worsening
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Posterior Vitreous Detachment
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Hyperkalemia
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Ptosis
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Ocular swelling
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Medicamentosa suspect
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Conjunctivitis
|
13.3%
2/15 • Number of events 3
|
0.00%
0/12
|
|
Eye disorders
Chronic angle closure glaucoma
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Lower extremity sprain
|
20.0%
3/15 • Number of events 4
|
0.00%
0/12
|
|
Eye disorders
Subconjunctival Hemorrhage
|
13.3%
2/15 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Tingling sensation in feet
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Puncture wound
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Elevated Heart Rate
|
6.7%
1/15 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Elevated FBS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Staph infection of wound on ankle
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Difficulty with watching television
|
6.7%
1/15 • Number of events 1
|
25.0%
3/12 • Number of events 3
|
|
General disorders
Addison's Disease worsening
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Worsening of trigger finger
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Elevated TSH levels
|
6.7%
1/15 • Number of events 1
|
0.00%
0/12
|
|
General disorders
SOB episode - allergy to Zanaflex
|
0.00%
0/15
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place