Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema (TRIASTIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00682539
Recruitment Status : Completed
First Posted : May 22, 2008
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Katharina Kriechbaum, Medical University of Vienna

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Drug: Bevacizumab (Avastin)
Drug: Triamcinolone
Drug: Sham
Procedure: Lucentis
Enrollment 71
Recruitment Details Study patients were recruited between 2007 and 2014 at the outpatient clinic of the Department of Ophthalmology, Medical University Vienna, Austria.
Pre-assignment Details  
Arm/Group Title Avastin Triamciolone Lucentis
Hide Arm/Group Description 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. 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. 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.
Period Title: Bevacizumab vs Triamcinolone
Started 18 16 0
Completed 15 15 0
Not Completed 3 1 0
Reason Not Completed
Lost to Follow-up             3             1             0
Period Title: Ranibizumab vs Triamcinolone
Started 0 [1] 18 [2] 18 [3]
Completed 0 15 10
Not Completed 0 3 8
Reason Not Completed
Lost to Follow-up             0             3             8
[1]
Two independent periods.
[2]
None of the patients of the 1st period was included in the second period.
[3]
Both periods recruited independently following the same criteria.
Arm/Group Title Avastin Triamciolone Lucentis Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 15 30 10 55
Hide Baseline Analysis Population Description
The sample size will be calculated so that a true group difference in changes of macular edema of 50 μm can be detected with a probability of 90 %. Repeated-measures-ANOVA will be used to reveal differences between macular edema measurements before and after treatment and between groups
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 30 participants 10 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  73.3%
19
  63.3%
6
  60.0%
36
  65.5%
>=65 years
4
  26.7%
11
  36.7%
4
  40.0%
19
  34.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 30 participants 10 participants 55 participants
Female
4
  26.7%
14
  46.7%
2
  20.0%
20
  36.4%
Male
11
  73.3%
16
  53.3%
8
  80.0%
35
  63.6%
1.Primary Outcome
Title Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.
Hide Description 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
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avastin Triamciolone Lucentis
Hide Arm/Group Description:
Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
Overall Number of Participants Analyzed 15 30 10
Mean (Standard Deviation)
Unit of Measure: logMAR
0.18  (0.12) 0.36  (0.19) 0.18  (0.15)
2.Primary Outcome
Title Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)
Hide Description 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 measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avastin Triamciolone Lucentis
Hide Arm/Group Description:
Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
Overall Number of Participants Analyzed 15 30 10
Mean (Standard Deviation)
Unit of Measure: µm
351  (93) 357  (152) 389  (137)
3.Secondary Outcome
Title To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.
Hide Description Area 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.
Time Frame 12 month
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Avastin Triamciolone Lucentis
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Avastin Triamciolone Lucentis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Avastin Triamciolone Lucentis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/30 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Avastin Triamciolone Lucentis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   7/30 (23.33%)   1/10 (10.00%) 
Eye disorders       
IOP elevation >25mmHg  0/15 (0.00%)  7/30 (23.33%)  1/10 (10.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Katharina Kriechbaum
Organization: Department of Ophthalmology, Medical University Vienna
Phone: 00431 40400 79480
Responsible Party: Katharina Kriechbaum, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00682539     History of Changes
Other Study ID Numbers: TRIASTIN Study
First Submitted: May 20, 2008
First Posted: May 22, 2008
Results First Submitted: November 6, 2015
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016