Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

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: NCT01427751
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : February 15, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Retinal Vein Occlusion
Macular Edema
Interventions Drug: dexamethasone intravitreal implant
Biological: ranibizumab
Enrollment 307
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter. Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Period Title: Overall Study
Started 154 153
Completed 112 139
Not Completed 42 14
Reason Not Completed
Adverse Event             18             2
No further treatment benefit expected             5             1
Lost to Follow-up             3             1
Withdrawal of consent             2             2
Protocol Violation             6             4
Death             2             0
Other miscellaneous reasons             6             4
Arm/Group Title Ozurdex® Lucentis® Total
Hide Arm/Group Description Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter. Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria. Total of all reporting groups
Overall Number of Baseline Participants 154 153 307
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 153 participants 307 participants
68.4  (10.58) 65.5  (12.04) 67.0  (11.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 153 participants 307 participants
Female
62
  40.3%
66
  43.1%
128
  41.7%
Male
92
  59.7%
87
  56.9%
179
  58.3%
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA)
Hide Description BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description:
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Overall Number of Participants Analyzed 154 153
Mean (Standard Deviation)
Unit of Measure: letters
Baseline (n=153,153) 56.6  (10.89) 59.2  (10.92)
Change from Baseline at Month 12 (n=153,151) 7.9  (14.42) 16.9  (12.08)
2.Secondary Outcome
Title Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
Hide Description Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description:
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Overall Number of Participants Analyzed 154 153
Mean (Standard Deviation)
Unit of Measure: microns
Baseline (n=149, 149) 553.2  (170.15) 561.0  (188.93)
Change from Baseline at Month 12 (n=140,144) -219.2  (180.51) -253.5  (197.08)
3.Secondary Outcome
Title Percentage of Patients With 15-or-More Letter Improvement in BCVA
Hide Description BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description:
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
33.8 59.5
4.Secondary Outcome
Title Percentage of Patients With a 15-or-More Letter Decrease in BCVA
Hide Description BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description:
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
9.1 0.7
5.Secondary Outcome
Title Time to BCVA Improvement of 15-or-More Letters
Hide Description BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description:
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Overall Number of Participants Analyzed 154 153
Mean (Standard Deviation)
Unit of Measure: days
73.7  (79.68) 82.0  (93.78)
6.Secondary Outcome
Title Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
Hide Description The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description:
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Overall Number of Participants Analyzed 154 153
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=143,139) 78.1  (16.58) 80.7  (14.34)
Change from Baseline at Month 12 (n=143, 139) 3.5  (12.21) 6.6  (13.45)
7.Secondary Outcome
Title Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
Hide Description Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants.
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description:
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
4.5 0.7
Time Frame Up to 60 Weeks
Adverse Event Reporting Description Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
 
Arm/Group Title Ozurdex® Lucentis®
Hide Arm/Group Description Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter. Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
All-Cause Mortality
Ozurdex® Lucentis®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ozurdex® Lucentis®
Affected / at Risk (%) Affected / at Risk (%)
Total   12/153 (7.84%)   16/150 (10.67%) 
Cardiac disorders     
Acute coronary syndrome  1  1/153 (0.65%)  0/150 (0.00%) 
Atrial fibrillation  1  1/153 (0.65%)  0/150 (0.00%) 
Bradyarrhythmia  1  1/153 (0.65%)  0/150 (0.00%) 
Angina pectoris  1  0/153 (0.00%)  1/150 (0.67%) 
Myocardial infarction  1  0/153 (0.00%)  1/150 (0.67%) 
Myocardial ischaemia  1  0/153 (0.00%)  1/150 (0.67%) 
Palpitations  1  0/153 (0.00%)  1/150 (0.67%) 
Ear and labyrinth disorders     
Vertigo  1  0/153 (0.00%)  1/150 (0.67%) 
Eye disorders     
Ocular hypertension  1  1/153 (0.65%)  0/150 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  1/153 (0.65%)  0/150 (0.00%) 
Diverticulum intestinal  1  0/153 (0.00%)  1/150 (0.67%) 
Gastric ulcer  1  0/153 (0.00%)  1/150 (0.67%) 
Haematemesis  1  0/153 (0.00%)  1/150 (0.67%) 
General disorders     
Chest pain  1  1/153 (0.65%)  0/150 (0.00%) 
Catheter site related reaction  1  0/153 (0.00%)  1/150 (0.67%) 
Infections and infestations     
Pneumonia  1  1/153 (0.65%)  0/150 (0.00%) 
Endophthalmitis  1  0/153 (0.00%)  1/150 (0.67%) 
Injury, poisoning and procedural complications     
Hip fracture  1  1/153 (0.65%)  1/150 (0.67%) 
Craniocerebral injury  1  0/153 (0.00%)  1/150 (0.67%) 
Post procedural complication  1  0/153 (0.00%)  1/150 (0.67%) 
Subdural haemorrhage  1  0/153 (0.00%)  1/150 (0.67%) 
Metabolism and nutrition disorders     
Dehydration  1  0/153 (0.00%)  1/150 (0.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/153 (0.65%)  0/150 (0.00%) 
Musculoskeletal pain  1  0/153 (0.00%)  1/150 (0.67%) 
Osteoarthritis  1  0/153 (0.00%)  1/150 (0.67%) 
Spinal column stenosis  1  0/153 (0.00%)  1/150 (0.67%) 
Nervous system disorders     
Cerebrovascular accident  1  1/153 (0.65%)  0/150 (0.00%) 
Transient ischaemic attack  1  1/153 (0.65%)  0/150 (0.00%) 
Subarachnoid haemorrhage  1  0/153 (0.00%)  1/150 (0.67%) 
Psychiatric disorders     
Agitated depression  1  1/153 (0.65%)  0/150 (0.00%) 
Confusional state  1  1/153 (0.65%)  0/150 (0.00%) 
Anxiety  1  0/153 (0.00%)  1/150 (0.67%) 
Renal and urinary disorders     
Renal failure chronic  1  1/153 (0.65%)  0/150 (0.00%) 
Renal failure  1  0/153 (0.00%)  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/153 (0.65%)  0/150 (0.00%) 
Respiratory distress  1  1/153 (0.65%)  0/150 (0.00%) 
Vascular disorders     
Thrombophlebitis superficial  1  1/153 (0.65%)  0/150 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ozurdex® Lucentis®
Affected / at Risk (%) Affected / at Risk (%)
Total   127/153 (83.01%)   104/150 (69.33%) 
Eye disorders     
Conjunctival haemorrhage  1  28/153 (18.30%)  17/150 (11.33%) 
Macular oedema  1  20/153 (13.07%)  4/150 (2.67%) 
Visual acuity reduced  1  18/153 (11.76%)  3/150 (2.00%) 
Cataract  1  13/153 (8.50%)  2/150 (1.33%) 
Lenticular opacities  1  10/153 (6.54%)  0/150 (0.00%) 
Ocular hypertension  1  9/153 (5.88%)  1/150 (0.67%) 
Blepharitis  1  9/153 (5.88%)  3/150 (2.00%) 
Dry eye  1  9/153 (5.88%)  7/150 (4.67%) 
Vitreous floaters  1  9/153 (5.88%)  9/150 (6.00%) 
Eye pain  1  6/153 (3.92%)  9/150 (6.00%) 
Conjunctivitis  1  6/153 (3.92%)  9/150 (6.00%) 
Infections and infestations     
Nasopharyngitis  1  8/153 (5.23%)  5/150 (3.33%) 
Investigations     
Intraocular pressure increased  1  50/153 (32.68%)  16/150 (10.67%) 
Nervous system disorders     
Headache  1  4/153 (2.61%)  9/150 (6.00%) 
Vascular disorders     
Hypertension  1  5/153 (3.27%)  10/150 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Allergan Inc.,
Organization: Allergan, Inc
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01427751     History of Changes
Other Study ID Numbers: MAF-AGN-OPH-RET-004
2010-023900-29 ( EudraCT Number )
First Submitted: August 31, 2011
First Posted: September 2, 2011
Results First Submitted: November 3, 2015
Results First Posted: February 15, 2016
Last Update Posted: April 18, 2019