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Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT01571232
Recruitment Status : Completed
First Posted : April 5, 2012
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Ron P. Gallemore, Retina Macula Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetic Macular Edema
Non-proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Interventions Drug: dexamethasone intravitreal implant
Drug: intravitreal bevacizumab
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ozurdex Avastin
Hide Arm/Group Description

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Period Title: Overall Study
Started 10 10
Completed 9 9
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             1             0
Arm/Group Title Ozurdex Avastin Total
Hide Arm/Group Description

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
63.9  (1.8) 61.2  (2.9) 62.6  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
3
  30.0%
8
  40.0%
Male
5
  50.0%
7
  70.0%
12
  60.0%
1.Primary Outcome
Title The Change in Visual Acuity (Number of ETDRS Letters).
Hide Description The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ozurdex Avastin
Hide Arm/Group Description:

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Overall Number of Participants Analyzed 9 10
Mean (Standard Error)
Unit of Measure: ETDRS letters
Baseline 67.8  (3.8) 71.9  (2.9)
Final Visit 69.6  (4.8) 72.9  (3.4)
2.Primary Outcome
Title The Change in Central Foveal Thickness (Microns on High Resolution OCT).
Hide Description The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ozurdex Avastin
Hide Arm/Group Description:

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Overall Number of Participants Analyzed 9 10
Mean (Standard Error)
Unit of Measure: microns
Baseline 385.9  (43.0) 341.5  (11.3)
Final Visit 305.4  (9.1) 324.3  (10.9)
3.Secondary Outcome
Title The Change in Macular Leakage on Fluorescein Angiography From Baseline
Hide Description To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
Time Frame 6 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Change in Mean Macular Sensitivity on Microperimetry From Baseline
Hide Description To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
Time Frame 6 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
Hide Description To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ozurdex Avastin
Hide Arm/Group Description:

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Overall Number of Participants Analyzed 8 7
Mean (Standard Error)
Unit of Measure: nV/deg2
Baseline 27.8  (4.3) 34.4  (11.0)
Final Visit 40.9  (3.8) 30.3  (6.5)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ozurdex Avastin
Hide Arm/Group Description

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

All-Cause Mortality
Ozurdex Avastin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ozurdex Avastin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (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 0%
Ozurdex Avastin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   0/10 (0.00%) 
Eye disorders     
Elevated Intraocular Pressure  [1]  1/10 (10.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Greater than 10 mmHg increase in intraocular pressure from baseline
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ron P. Gallemore M.D., Ph.D.
Organization: Retina Macula Institute
Phone: 310-944-9393
Responsible Party: Ron P. Gallemore, Retina Macula Institute
ClinicalTrials.gov Identifier: NCT01571232     History of Changes
Other Study ID Numbers: IIT-406
First Submitted: April 2, 2012
First Posted: April 5, 2012
Results First Submitted: April 26, 2017
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017