Trial Outcomes & Findings for Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema (NCT NCT00682539)
NCT ID: NCT00682539
Last Updated: 2016-04-04
Results Overview
Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
12 month
Results posted on
2016-04-04
Participant Flow
Study patients were recruited between 2007 and 2014 at the outpatient clinic of the Department of Ophthalmology, Medical University Vienna, Austria.
Participant milestones
| Measure |
Avastin
15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.
|
Triamciolone
30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
|
Lucentis
15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.
|
|---|---|---|---|
|
Bevacizumab vs Triamcinolone
STARTED
|
18
|
16
|
0
|
|
Bevacizumab vs Triamcinolone
COMPLETED
|
15
|
15
|
0
|
|
Bevacizumab vs Triamcinolone
NOT COMPLETED
|
3
|
1
|
0
|
|
Ranibizumab vs Triamcinolone
STARTED
|
0
|
18
|
18
|
|
Ranibizumab vs Triamcinolone
COMPLETED
|
0
|
15
|
10
|
|
Ranibizumab vs Triamcinolone
NOT COMPLETED
|
0
|
3
|
8
|
Reasons for withdrawal
| Measure |
Avastin
15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.
|
Triamciolone
30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
|
Lucentis
15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.
|
|---|---|---|---|
|
Bevacizumab vs Triamcinolone
Lost to Follow-up
|
3
|
1
|
0
|
|
Ranibizumab vs Triamcinolone
Lost to Follow-up
|
0
|
3
|
8
|
Baseline Characteristics
Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Avastin
n=15 Participants
After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
|
Triamciolone
n=30 Participants
Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.
|
Lucentis
n=10 Participants
After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
|
Total
n=55 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthEfficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome
Outcome measures
| Measure |
Avastin
n=15 Participants
Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
|
Triamciolone
n=30 Participants
Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
|
Lucentis
n=10 Participants
Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
|
|---|---|---|---|
|
Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.
|
0.18 logMAR
Standard Deviation 0.12
|
0.36 logMAR
Standard Deviation 0.19
|
0.18 logMAR
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 12 monthsEfficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome
Outcome measures
| Measure |
Avastin
n=15 Participants
Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
|
Triamciolone
n=30 Participants
Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
|
Lucentis
n=10 Participants
Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
|
|---|---|---|---|
|
Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)
|
351 µm
Standard Deviation 93
|
357 µm
Standard Deviation 152
|
389 µm
Standard Deviation 137
|
SECONDARY outcome
Timeframe: 12 monthArea of leakage and non perfusion is measured in FA, morphologic details like presence of cysts or sub retinal fluid is evaluated in OCT. Data is still under evaluation.
Outcome measures
Outcome data not reported
Adverse Events
Avastin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triamciolone
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Lucentis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Avastin
n=15 participants at risk
Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.
|
Triamciolone
n=30 participants at risk
30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
|
Lucentis
n=10 participants at risk
15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.
|
|---|---|---|---|
|
Eye disorders
IOP elevation >25mmHg
|
0.00%
0/15
|
23.3%
7/30
|
10.0%
1/10
|
Additional Information
Dr. Katharina Kriechbaum
Department of Ophthalmology, Medical University Vienna
Phone: 00431 40400 79480
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place