Trial Outcomes & Findings for Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions (NCT NCT01003106)
NCT ID: NCT01003106
Last Updated: 2016-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
81 participants
Primary outcome timeframe
36 months
Results posted on
2016-03-15
Participant Flow
Eighty-one patients with retinal vein occlusion were enrolled at a single center (The Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore,MD).
Participant milestones
| Measure |
BRVO- Ranibizumab 0.5mg Alone
Branch retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg of ranibizumab alone for 6 months.
|
BRVO- Ranibizumab 2.0mg Alone
Branch retinal vein occlusion patients randomized to this group at baseline will receive 2.0mg of Ranibizumab alone for 6 months.
|
BRVO- Pro re Nata (Prn) Ranibizumab Alone
Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata 0.5mg/2.0mg of ranibizumab without laser photocoagulation.
|
BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation
Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) ranibizumab along with laser photocoagulation.
|
CRVO- Ranibizumab 0.5mg Alone
Central retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg at of ranibizumab alone for 6 months.
|
CRVO- Ranibizumab 2.0mg Alone
Central retinal vein occlusion patients randomized to this group at baseline will receive ranibizumab 2.0mg alone for 6 months .
|
CRVO- Pro re Nata (Prn) Ranibizumab Alone
Central retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
|
CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation
Central retinal vein occlusion patients randomized to this group at month 6 will receive 0.5mg/2.0mg prn ranibizumab along with laser photocoagulation.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline to Month 6
STARTED
|
22
|
20
|
0
|
0
|
19
|
20
|
0
|
0
|
|
Baseline to Month 6
COMPLETED
|
22
|
20
|
0
|
0
|
19
|
20
|
0
|
0
|
|
Baseline to Month 6
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Month 6-Month 36
STARTED
|
0
|
0
|
19
|
20
|
0
|
0
|
20
|
18
|
|
Month 6-Month 36
COMPLETED
|
0
|
0
|
18
|
20
|
0
|
0
|
19
|
18
|
|
Month 6-Month 36
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Baseline characteristics by cohort
| Measure |
BRVO- Ranibizumab 0.5mg Alone
n=22 Participants
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
BRVO -Ranibizumab 0.5mg alone: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
|
BRVO- Ranibizumab 2.0mg Alone
n=20 Participants
Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
BRVO- Ranibizumab 2.0 mg alone: Branch retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone
|
CRVO- Ranibizumab 0.5mg Alone
n=19 Participants
Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
CRVO -Ranibizumab 0.5mg alone: Central retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
|
CRVO- Ranibizumab 2.0mg Alone
n=20 Participants
Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
CRVO- Ranibizumab 2.0 mg alone: Central retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 2.9 • n=4 Participants
|
64.7 years
STANDARD_DEVIATION 2.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
BRVO
n=42 Participants
Patients with Branch Retinal Vein Occlusion
|
CRVO
n=39 Participants
Patients with Central Retinal Vein Occlusion
|
CRVO- Ranibizumab 0.5mg Alone
Patients randomized to receive 0.5mg of ranibizumab alone
|
CRVO- Ranibizumab 2.0mg Alone
Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
|
|---|---|---|---|---|
|
Incidence and Severity of Ocular and Non-ocular Adverse Events.
Patients with Serious Adverse Events
|
17 participants
|
12 participants
|
—
|
—
|
|
Incidence and Severity of Ocular and Non-ocular Adverse Events.
Patient with (non serious) adverse events
|
37 participants
|
35 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to month 6Outcome measures
| Measure |
BRVO
n=22 Participants
Patients with Branch Retinal Vein Occlusion
|
CRVO
n=20 Participants
Patients with Central Retinal Vein Occlusion
|
CRVO- Ranibizumab 0.5mg Alone
n=19 Participants
Patients randomized to receive 0.5mg of ranibizumab alone
|
CRVO- Ranibizumab 2.0mg Alone
n=20 Participants
Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
|
12.1 Letters
Standard Error 2.9
|
14.6 Letters
Standard Error 2.3
|
15.5 Letters
Standard Error 2.4
|
15.8 Letters
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Month 6- Month 36Outcome measures
| Measure |
BRVO
n=18 Participants
Patients with Branch Retinal Vein Occlusion
|
CRVO
n=20 Participants
Patients with Central Retinal Vein Occlusion
|
CRVO- Ranibizumab 0.5mg Alone
n=19 Participants
Patients randomized to receive 0.5mg of ranibizumab alone
|
CRVO- Ranibizumab 2.0mg Alone
n=18 Participants
Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
|
|---|---|---|---|---|
|
Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.
|
3.1 Letters
Standard Error 3.3
|
-2.6 Letters
Standard Error 2.2
|
-6.7 Letters
Standard Error 3.7
|
0.4 Letters
Standard Error 4.3
|
SECONDARY outcome
Timeframe: Baseline to month 6Outcome measures
| Measure |
BRVO
n=22 Participants
Patients with Branch Retinal Vein Occlusion
|
CRVO
n=20 Participants
Patients with Central Retinal Vein Occlusion
|
CRVO- Ranibizumab 0.5mg Alone
n=19 Participants
Patients randomized to receive 0.5mg of ranibizumab alone
|
CRVO- Ranibizumab 2.0mg Alone
n=20 Participants
Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
|
|---|---|---|---|---|
|
Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
|
-203.3 microns
Standard Error 41
|
-292.1 microns
Standard Error 55
|
-253.5 microns
Standard Error 43
|
-396.1 microns
Standard Error 48.1
|
SECONDARY outcome
Timeframe: Month 6- Month 36Outcome measures
| Measure |
BRVO
n=18 Participants
Patients with Branch Retinal Vein Occlusion
|
CRVO
n=20 Participants
Patients with Central Retinal Vein Occlusion
|
CRVO- Ranibizumab 0.5mg Alone
n=19 Participants
Patients randomized to receive 0.5mg of ranibizumab alone
|
CRVO- Ranibizumab 2.0mg Alone
n=18 Participants
Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
|
|---|---|---|---|---|
|
Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.
|
-3.2 microns
Standard Error 54.7
|
36.6 microns
Standard Error 29.2
|
19.1 microns
Standard Error 50.3
|
58.8 microns
Standard Error 38.5
|
Adverse Events
BRVO
Serious events: 17 serious events
Other events: 37 other events
Deaths: 0 deaths
CRVO
Serious events: 12 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BRVO
n=42 participants at risk
Patients with Branch Retinal Vein Occlusion
|
CRVO
n=39 participants at risk
Patients with Central Retinal Vein Occlusion
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection Requiring Hospitalization
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Eye disorders
Worsening of Cataract/Cataract Surgery
|
7.1%
3/42 • Number of events 3 • From Baseline to Month 36
|
5.1%
2/39 • Number of events 2 • From Baseline to Month 36
|
|
Cardiac disorders
Hospitalization for Heart Failure
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Surgical and medical procedures
Vertebral Fracture/Surgery
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Nervous system disorders
Cerebrovascular event
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Infections and infestations
Hospitalization for Septic Shock
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Musculoskeletal and connective tissue disorders
Knee surgery
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Eye disorders
Vitreous Hemorrhage resulting in significant visual loss
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Blood and lymphatic system disorders
Severe Anemia
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Renal and urinary disorders
Kidney Surgery
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Eye disorders
Trabulectomy
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Cardiac disorders
Severe Cheat pain/Acute Coronary Syndrome
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
7.7%
3/39 • Number of events 3 • From Baseline to Month 36
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Gastrointestinal disorders
Colon Surgery
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
General disorders
Hospitalization due to multiple systemic diseases
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Nervous system disorders
Brain Surgery
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Nervous system disorders
Transient global Amnesia
|
2.4%
1/42 • Number of events 1 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Injury, poisoning and procedural complications
Serious Drug Allergy requiring Hospitalization
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Blood and lymphatic system disorders
Hypertensive Crisis
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Eye disorders
Surgery for Macular Pucker
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Endocrine disorders
Hospitalization for Thyroiditis
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Endocrine disorders
Parotid Gland Swelling
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Gastrointestinal disorders
Pancreatic Mass
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/42 • From Baseline to Month 36
|
2.6%
1/39 • Number of events 1 • From Baseline to Month 36
|
Other adverse events
| Measure |
BRVO
n=42 participants at risk
Patients with Branch Retinal Vein Occlusion
|
CRVO
n=39 participants at risk
Patients with Central Retinal Vein Occlusion
|
|---|---|---|
|
Eye disorders
Increased IOP
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
General disorders
Tooth Extraction
|
7.1%
3/42 • Number of events 3 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Skin and subcutaneous tissue disorders
Skin Lesion/Skin Rash
|
9.5%
4/42 • Number of events 4 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
9.5%
4/42 • Number of events 4 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
General disorders
Headache
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
General disorders
Common Cold/cough
|
23.8%
10/42 • Number of events 10 • From Baseline to Month 36
|
25.6%
10/39 • Number of events 10 • From Baseline to Month 36
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 3 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
General disorders
Sinusitis
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
7.7%
3/39 • Number of events 3 • From Baseline to Month 36
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Musculoskeletal and connective tissue disorders
Worsening Arthritis
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
12.8%
5/39 • Number of events 5 • From Baseline to Month 36
|
|
Gastrointestinal disorders
Hernia Repair Surgery
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
General disorders
Fall
|
4.8%
2/42 • Number of events 2 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
General disorders
Back Pain
|
11.9%
5/42 • Number of events 5 • From Baseline to Month 36
|
0.00%
0/39 • From Baseline to Month 36
|
|
Renal and urinary disorders
Urinary Tract Infection
|
16.7%
7/42 • Number of events 7 • From Baseline to Month 36
|
17.9%
7/39 • Number of events 7 • From Baseline to Month 36
|
|
Eye disorders
Blurry vision
|
0.00%
0/42 • From Baseline to Month 36
|
10.3%
4/39 • Number of events 4 • From Baseline to Month 36
|
|
Eye disorders
Vitreous Hemorrhage
|
0.00%
0/42 • From Baseline to Month 36
|
5.1%
2/39 • Number of events 2 • From Baseline to Month 36
|
|
Skin and subcutaneous tissue disorders
Squamous Cell/Basal Cell Carcinoma
|
0.00%
0/42 • From Baseline to Month 36
|
7.7%
3/39 • Number of events 3 • From Baseline to Month 36
|
|
General disorders
Worsening Hypercholesterlemia
|
0.00%
0/42 • From Baseline to Month 36
|
5.1%
2/39 • Number of events 2 • From Baseline to Month 36
|
|
Musculoskeletal and connective tissue disorders
Foot Injury
|
0.00%
0/42 • From Baseline to Month 36
|
5.1%
2/39 • Number of events 2 • From Baseline to Month 36
|
|
General disorders
Seasonal Allergy
|
0.00%
0/42 • From Baseline to Month 36
|
7.7%
3/39 • Number of events 3 • From Baseline to Month 36
|
|
General disorders
Gout
|
0.00%
0/42 • From Baseline to Month 36
|
7.7%
3/39 • Number of events 3 • From Baseline to Month 36
|
Additional Information
Peter A. Campochiaro, MD
Wilmer Eye Institute, Johns Hopkins University School of Medicine
Phone: (410) 955-5106
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place