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Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

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ClinicalTrials.gov Identifier: NCT01085734
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Retinal Vein Occlusions
Interventions Drug: Avastin
Drug: Osurdex
Enrollment 30
Recruitment Details The study was conducted at a single center. The first subject for this study was screened on 18MAR2010 and enrolled on 26MAR2010. The subjects were existing patients in our medical clinic.
Pre-assignment Details In total there were 10 screen failures; 4 did not meet the visual acuity requirements,3 did not meet the OCT requirements. One subject withdrew consent prior to randomization and one withdrew prior to randomization due to health issues
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
Period Title: Overall Study
Started 15 15
Completed 14 11
Not Completed 1 4
Reason Not Completed
Adverse Event             0             2
Death             1             0
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  40.0%
4
  26.7%
10
  33.3%
>=65 years
9
  60.0%
11
  73.3%
20
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
67  (13) 69  (19) 68  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
5
  33.3%
7
  46.7%
12
  40.0%
Male
10
  66.7%
8
  53.3%
18
  60.0%
1.Primary Outcome
Title Change From Baseline Visual Acuity at 6 Months
Hide Description Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: ETDRS score
2.3  (7.7) 0.1  (13.3)
2.Secondary Outcome
Title Number of Injections Needed
Hide Description number of Avastin and Ozurdex injections needed
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
Overall Number of Participants Analyzed 14 11
Measure Type: Number
Unit of Measure: injections
14 11
3.Secondary Outcome
Title Change in Macular Thickness and Macular Volume
Hide Description OCT central subfield thickness measured in microns
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: microns
45.4  (100.1) -55.6  (39.7)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/15 (26.67%)      3/15 (20.00%)    
Immune system disorders     
viral influenza †  0/15 (0.00%)  0 1/15 (6.67%)  1
organ transplant rejection †  1/15 (6.67%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders     
osteoarthritis †  1/15 (6.67%)  1 0/15 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
breast cancer † 1  1/15 (6.67%)  1 0/15 (0.00%)  0
esophageal cancer †  1/15 (6.67%)  1 0/15 (0.00%)  0
colon cancer †  0/15 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
pneumonia † 1  0/15 (0.00%)  0 1/15 (6.67%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/15 (86.67%)      15/15 (100.00%)    
Blood and lymphatic system disorders     
anemia †  1/15 (6.67%)  1 0/15 (0.00%)  0
Cardiac disorders     
worsening of hypertension †  1/15 (6.67%)  1 1/15 (6.67%)  1
Ear and labyrinth disorders     
Meniere's disease †  1/15 (6.67%)  1 0/15 (0.00%)  0
sinusitis †  1/15 (6.67%)  1 0/15 (0.00%)  0
inner ear infection †  0/15 (0.00%)  0 1/15 (6.67%)  1
auditory disturbance †  0/15 (0.00%)  0 1/15 (6.67%)  1
Eye disorders     
worsening of cataract †  1/15 (6.67%)  1 3/15 (20.00%)  3
increased intraocular pressure †  1/15 (6.67%)  1 1/15 (6.67%)  1
worsening of epiretinal membrane †  0/15 (0.00%)  0 1/15 (6.67%)  1
subconjunctival hemorrhage †  1/15 (6.67%)  1 0/15 (0.00%)  0
vitreous floaters †  0/15 (0.00%)  0 2/15 (13.33%)  2
blurry vision †  0/15 (0.00%)  0 1/15 (6.67%)  1
discomfort right eye †  1/15 (6.67%)  1 0/15 (0.00%)  0
General disorders     
generalized weakness †  0/15 (0.00%)  0 1/15 (6.67%)  1
headache †  0/15 (0.00%)  0 1/15 (6.67%)  1
Hepatobiliary disorders     
nonfunctioning gallbladder †  0/15 (0.00%)  0 1/15 (6.67%)  1
cholescystitis †  1/15 (6.67%)  1 0/15 (0.00%)  0
Infections and infestations     
infection left foot †  0/15 (0.00%)  0 1/15 (6.67%)  1
tooth infection †  1/15 (6.67%)  1 0/15 (0.00%)  0
Injury, poisoning and procedural complications     
puncture wounds to hands †  0/15 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
back pain †  1/15 (6.67%)  1 1/15 (6.67%)  1
osteoporosis †  1/15 (6.67%)  1 1/15 (6.67%)  1
contusion left foot †  0/15 (0.00%)  0 1/15 (6.67%)  1
knee pain †  0/15 (0.00%)  0 1/15 (6.67%)  1
Renal and urinary disorders     
urinary incontinence †  0/15 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
cough †  0/15 (0.00%)  0 2/15 (13.33%)  2
pneumonia †  0/15 (0.00%)  0 2/15 (13.33%)  2
bronchitis †  0/15 (0.00%)  0 2/15 (13.33%)  2
nasal congestion †  1/15 (6.67%)  1 0/15 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Raj K. Maturi, MD
Organization: Raj K. Maturi, MD, PC
Phone: 317-817-1414
EMail: rmaturi@gmail.com
Layout table for additonal information
Responsible Party: Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT01085734    
Other Study ID Numbers: OA001
First Submitted: March 10, 2010
First Posted: March 12, 2010
Results First Submitted: April 24, 2013
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014