Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (COBALT)

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: NCT00499590
Recruitment Status : Terminated
First Posted : July 11, 2007
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Macular Degeneration
Interventions Drug: bevasiranib
Drug: ranibizumab
Enrollment 338
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lucentis® Bevasiranib 8 Weeks Bevasiranib 12 Weeks
Hide Arm/Group Description

Lucentis® (0.5mg) every 4 weeks.

ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.

bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.

bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Period Title: Overall Study
Started 113 112 113
Completed 0 0 0
Not Completed 113 112 113
Reason Not Completed
Study Terminated             112             112             112
Not treated             1             0             1
Arm/Group Title Lucentis Bevasiranib 8 Weeks Bevasiranib 12 Weeks Total
Hide Arm/Group Description

Lucentis® (0.5mg) every 4 weeks.

ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.

bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.

bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 113 112 113 338
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 113 participants 112 participants 113 participants 338 participants
77.6
(56 to 90)
77.2
(52 to 95)
78.3
(57 to 94)
77.7
(52 to 95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 112 participants 113 participants 338 participants
Female
80
  70.8%
72
  64.3%
59
  52.2%
211
  62.4%
Male
33
  29.2%
40
  35.7%
54
  47.8%
127
  37.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 112 participants 113 participants 338 participants
United States 61 59 64 184
Austria 4 5 4 13
Canada 8 10 5 23
France 22 24 20 66
Israel 9 7 6 22
Italy 5 2 2 9
Portugal 3 3 5 11
Spain 1 2 7 10
1.Primary Outcome
Title Visual Acuity
Hide Description avoidance of 3 or more lines of vision loss
Time Frame week 60
Outcome Measure Data Not Reported
2.Secondary Outcome
Title Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision
Hide Description [Not Specified]
Time Frame Week 60
Outcome Measure Data Not Reported
Time Frame Study was terminated early. Adverse events collected from first enrolled until study terminated, approximately 20 months.
Adverse Event Reporting Description Safety population included randomized participants who received at least one treatment. Therefore the number of participants analyzed in the Lucentis and Bevasiranib 12 Weeks is one participant fewer than the number of participants randomized.
 
Arm/Group Title Lucentis Bevasiranib 8 Weeks Bevasiranib 12 Weeks
Hide Arm/Group Description

Lucentis® (0.5mg) every 4 weeks.

ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.

bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.

bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

All-Cause Mortality
Lucentis Bevasiranib 8 Weeks Bevasiranib 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Lucentis Bevasiranib 8 Weeks Bevasiranib 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/112 (23.21%)   28/112 (25.00%)   33/112 (29.46%) 
Blood and lymphatic system disorders       
Anaemia *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Cardiac disorders       
Atrial fibrillation *  1/112 (0.89%)  1/112 (0.89%)  0/112 (0.00%) 
Myocardial infarction *  1/112 (0.89%)  1/112 (0.89%)  0/112 (0.00%) 
Acute myocardial infarction *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Angina pectoris *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Coronary artery disease *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Ear and labyrinth disorders       
Vertigo *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Eye disorders       
Visual acuity decreased *  5/112 (4.46%)  7/112 (6.25%)  10/112 (8.93%) 
Endophthalmitis *  0/112 (0.00%)  4/112 (3.57%)  1/112 (0.89%) 
Uveitis *  0/112 (0.00%)  1/112 (0.89%)  2/112 (1.79%) 
Vitritis *  0/112 (0.00%)  3/112 (2.68%)  0/112 (0.00%) 
Vitreous haemorrhage *  0/112 (0.00%)  0/112 (0.00%)  2/112 (1.79%) 
Cataract *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Corneal oedema *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Hyphaema *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Iridocyclitis *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Macular degeneration *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Punctate keratitis *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Gastroduodenitis *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Gastrointestinal haemorrhage *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Intestinal obstruction *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Pancreatitis *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
General disorders       
Asthenia *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Immune system disorders       
Anaphylactic reaction *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Infections and infestations       
Pneumonia *  1/112 (0.89%)  0/112 (0.00%)  2/112 (1.79%) 
Bronchitis *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Gastroenteritis viral *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Keratitis herpetic *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Injury, poisoning and procedural complications       
Fall *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Hip fracture *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Injury *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Upper limb fracture *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Investigations       
Heart rate irregular *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Metabolism and nutrition disorders       
Dehydration *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Hyponatraemia *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Musculoskeletal and connective tissue disorders       
Back pain *  1/112 (0.89%)  1/112 (0.89%)  0/112 (0.00%) 
Arthritis *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Intervertebral disc protusion *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Musculoskeletal chest pain *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Rhabdomyolysis *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer *  0/112 (0.00%)  2/112 (1.79%)  0/112 (0.00%) 
Colon cancer recurrent *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Lung neoplasm malignant *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Metastases to spine *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Nervous system disorders       
Cerebrovascular accident *  2/112 (1.79%)  0/112 (0.00%)  2/112 (1.79%) 
Syncope *  0/112 (0.00%)  0/112 (0.00%)  2/112 (1.79%) 
Transient ischemia attack *  0/112 (0.00%)  0/112 (0.00%)  2/112 (1.79%) 
Carotid artery stenosis *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Dementia *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Headache *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Renal and urinary disorders       
Renal failure chronic *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism *  0/112 (0.00%)  2/112 (1.79%)  0/112 (0.00%) 
Acute respiratory failure *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Chronic obstructive pulmonary disease *  0/112 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Pleural effusion *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Respiratory failure *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Vascular disorders       
Deep vein thrombosis *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Hypotension *  1/112 (0.89%)  0/112 (0.00%)  0/112 (0.00%) 
Thrombosis *  0/112 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lucentis Bevasiranib 8 Weeks Bevasiranib 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   71/112 (63.39%)   85/112 (75.89%)   96/112 (85.71%) 
Eye disorders       
Retinal haemorrhage *  11/112 (9.82%)  16/112 (14.29%)  22/112 (19.64%) 
Visual acuity reduced *  4/112 (3.57%)  8/112 (7.14%)  12/112 (10.71%) 
Conjunctival haemorrhage *  10/112 (8.93%)  9/112 (8.04%)  13/112 (11.61%) 
Vitreous detachment *  8/112 (7.14%)  11/112 (9.82%)  10/112 (8.93%) 
Vitreous floaters *  9/112 (8.04%)  10/112 (8.93%)  8/112 (7.14%) 
Eye pain *  6/112 (5.36%)  7/112 (6.25%)  12/112 (10.71%) 
Macular degeneration *  5/112 (4.46%)  7/112 (6.25%)  9/112 (8.04%) 
Cataract *  8/112 (7.14%)  4/112 (3.57%)  6/112 (5.36%) 
Infections and infestations       
Nasopharyngitis *  7/112 (6.25%)  6/112 (5.36%)  5/112 (4.46%) 
Investigations       
Intraocular pressure increased *  3/112 (2.68%)  7/112 (6.25%)  10/112 (8.93%) 
*
Indicates events were collected by non-systematic assessment
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: Jane Hsiao, PhD, MBA
Organization: OPKO Health, Inc.
Phone: 305-575-6004
EMail: jhsiao@opko.com
Layout table for additonal information
Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT00499590    
Other Study ID Numbers: ACU301
First Submitted: July 10, 2007
First Posted: July 11, 2007
Results First Submitted: September 25, 2014
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014