A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO
Primary Purpose
Central Retinal Vein Occlusion, Macular Edema
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
ranibizumab
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring ranibizumab, CRVO, macular edema, sham
Eligibility Criteria
Inclusion Criteria:
- Male and female ≥ 50 years
- Patients who have findings consistent with CRVO
- Patients who have a history of decreased visual acuity ≤ 6 months
- Patients who have a best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73 (4 m distance) or ≥ 6 (1 m distance) using an ETDRS chart
- Patients who have a macular edema verified by OCT
Patients who have macular edema in the study eye with the following characteristics as determined by fluorescein angiography:
- secondary to non-iscemic CRVO defined as non-perfusion < 10 DA OR
- secondary to ischemic CRVO defined as non-perfusion > 10 DA
- Willing and able to give written informed consent and who are willing and able to comply with study procedures
- Ability to cooperate with photo and OCT examinations
Exclusion Criteria:
- Neovascularisations in the study eye at baseline
- Previous treatment with or participation in a clinical trial (for either eye) involving anti-angiogenics drugs
- Use of other investigational drugs
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
- History of submacular surgery in the study eye, glaucoma filtration, corneal transplantation surgery
- Previous or current intravitreal or sub-Tenon drug delivery in the study eye
- Laserphotocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline
- Extracapsular extraction of cataract with phacoemulcification within three months preceding Baseline, or a history of post-complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis etc)
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)
- Previous violation of the posterior capsule in the study eye unless it occurred as a result of YAG laser posterior capsulotomy in assosiation with prior, posterior chamber lens implantation
- Afakia with absence of the posterior capsule in the study eye
- Active intraocular inflammation in the study eye
- Any active infection involving the ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as ideopathic or autoimmune-associated uveitis in either eye
- Vitreous hemorrhage or history og rhegmatogenous retinal detachment or macular hole in the study eye
- Any current intraocular condition in the study eye (cataract or diabetic retinopathia) that in the opinion of the investigator, could either require medical or surgical intervention during the study period for the next 6 months
- Ocular condition that requires chronic concomitant therapy with systemic or topical ocular corticosteroids.
- Current treatment for active systemic infection.
- Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve.
- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or might affect interpretation of the results of the study or render the subject at high risk for treatment complications
- History of hypersensitivity or allergy to fluorescein
- Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed
- Pregnant or nursing (lactating) women
- Pre-menopausal women of child-bearing potential not using adequate contraception.
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrance or metastases.
Sites / Locations
- Bettina Kinge, Retinaklinikken Aleris
- Ingar Stene Johansen
- Vegard Forsaa
- Kristian Fossen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
A
B
Arm Description
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection
Outcomes
Primary Outcome Measures
The primary efficacy outcome measure is the mean change from baseline in BCVA score
Secondary Outcome Measures
Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale.
Full Information
NCT ID
NCT00567697
First Posted
December 3, 2007
Last Updated
January 18, 2012
Sponsor
Aleris Helse
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00567697
Brief Title
A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO
Official Title
A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aleris Helse
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion, Macular Edema
Keywords
ranibizumab, CRVO, macular edema, sham
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection
Arm Title
B
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Intervention Description
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Intervention Description
Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.
Primary Outcome Measure Information:
Title
The primary efficacy outcome measure is the mean change from baseline in BCVA score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female ≥ 50 years
Patients who have findings consistent with CRVO
Patients who have a history of decreased visual acuity ≤ 6 months
Patients who have a best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73 (4 m distance) or ≥ 6 (1 m distance) using an ETDRS chart
Patients who have a macular edema verified by OCT
Patients who have macular edema in the study eye with the following characteristics as determined by fluorescein angiography:
secondary to non-iscemic CRVO defined as non-perfusion < 10 DA OR
secondary to ischemic CRVO defined as non-perfusion > 10 DA
Willing and able to give written informed consent and who are willing and able to comply with study procedures
Ability to cooperate with photo and OCT examinations
Exclusion Criteria:
Neovascularisations in the study eye at baseline
Previous treatment with or participation in a clinical trial (for either eye) involving anti-angiogenics drugs
Use of other investigational drugs
Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
History of submacular surgery in the study eye, glaucoma filtration, corneal transplantation surgery
Previous or current intravitreal or sub-Tenon drug delivery in the study eye
Laserphotocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline
Extracapsular extraction of cataract with phacoemulcification within three months preceding Baseline, or a history of post-complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis etc)
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)
Previous violation of the posterior capsule in the study eye unless it occurred as a result of YAG laser posterior capsulotomy in assosiation with prior, posterior chamber lens implantation
Afakia with absence of the posterior capsule in the study eye
Active intraocular inflammation in the study eye
Any active infection involving the ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as ideopathic or autoimmune-associated uveitis in either eye
Vitreous hemorrhage or history og rhegmatogenous retinal detachment or macular hole in the study eye
Any current intraocular condition in the study eye (cataract or diabetic retinopathia) that in the opinion of the investigator, could either require medical or surgical intervention during the study period for the next 6 months
Ocular condition that requires chronic concomitant therapy with systemic or topical ocular corticosteroids.
Current treatment for active systemic infection.
Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve.
History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or might affect interpretation of the results of the study or render the subject at high risk for treatment complications
History of hypersensitivity or allergy to fluorescein
Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed
Pregnant or nursing (lactating) women
Pre-menopausal women of child-bearing potential not using adequate contraception.
History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrance or metastases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Kinge, MD DMSc
Organizational Affiliation
Aleris Helse, Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bettina Kinge, Retinaklinikken Aleris
City
Oslo
ZIP/Postal Code
0264
Country
Norway
Facility Name
Ingar Stene Johansen
City
Oslo
Country
Norway
Facility Name
Vegard Forsaa
City
Stavanger
Country
Norway
Facility Name
Kristian Fossen
City
Tromsø
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
20591399
Citation
Kinge B, Stordahl PB, Forsaa V, Fossen K, Haugstad M, Helgesen OH, Seland J, Stene-Johansen I. Efficacy of ranibizumab in patients with macular edema secondary to central retinal vein occlusion: results from the sham-controlled ROCC study. Am J Ophthalmol. 2010 Sep;150(3):310-4. doi: 10.1016/j.ajo.2010.03.028. Epub 2010 Jun 29.
Results Reference
derived
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A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO
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