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A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO
This study is currently recruiting participants.
Verified by Aleris Helse, October 2006
Sponsors and Collaborators: Aleris Helse
Novartis
Information provided by: Aleris Helse
ClinicalTrials.gov Identifier: NCT00567697
  Purpose

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.


Condition Intervention Phase
Central Retinal Vein Occlusion
Macular Edema
Drug: ranibizumab
Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab Amphetamine Methamphetamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Aleris Helse:

Primary Outcome Measures:
  • The primary efficacy outcome measure is the mean change from baseline in BCVA score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: March 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
A: Active Comparator
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection
Drug: ranibizumab
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.
B: Sham Comparator Drug: ranibizumab
Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female ≥ 50 years
  2. Patients who have findings consistent with CRVO
  3. Patients who have a history of decreased visual acuity ≤ 6 months
  4. 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
  5. Patients who have a macular edema verified by OCT
  6. 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
  7. Willing and able to give written informed consent and who are willing and able to comply with study procedures
  8. Ability to cooperate with photo and OCT examinations

Exclusion Criteria:

  1. Neovascularisations in the study eye at baseline
  2. Previous treatment with or participation in a clinical trial (for either eye) involving anti-angiogenics drugs
  3. Use of other investigational drugs
  4. Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
  5. History of submacular surgery in the study eye, glaucoma filtration, corneal transplantation surgery
  6. Previous or current intravitreal or sub-Tenon drug delivery in the study eye
  7. Laserphotocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline
  8. 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)
  9. History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)
  10. 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
  11. Afakia with absence of the posterior capsule in the study eye
  12. Active intraocular inflammation in the study eye
  13. Any active infection involving the ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as ideopathic or autoimmune-associated uveitis in either eye
  14. Vitreous hemorrhage or history og rhegmatogenous retinal detachment or macular hole in the study eye
  15. 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
  16. Ocular condition that requires chronic concomitant therapy with systemic or topical ocular corticosteroids.
  17. Current treatment for active systemic infection.
  18. Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve.
  19. 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
  20. History of hypersensitivity or allergy to fluorescein
  21. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed
  22. Pregnant or nursing (lactating) women
  23. Pre-menopausal women of child-bearing potential not using adequate contraception.
  24. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567697

Contacts
Contact: Bettina Kinge, MD DMSc Bettina.Kinge@retinaklinikken.no

Locations
Norway
Bettina Kinge, Retinaklinikken Aleris Recruiting
Oslo, Norway, 0264
Contact: Bettina Kinge, MD DMSc         Bettina.Kinge@retinaklinikken.no    
Contact: Per Bjorn Stordahl, MD         per.bjorn.stordahl@retinaklinikken.no    
Principal Investigator: Bettina Kinge            
Ingar Stene Johansen Recruiting
Oslo, Norway
Contact: Ingar Stene-Joohansen         ingar.stene-johansen@ulleval.no    
Sub-Investigator: Ingar Stene-Johansen            
Vegard Forsaa Recruiting
Stavanger, Norway
Contact: Vegard Forsaa         forsaa@gmail.com    
Kristian Fossen Recruiting
Tromsø, Norway
Contact: Kristian Fossen         Kristian.Fossen@unn.no    
Sponsors and Collaborators
Aleris Helse
Novartis
Investigators
Principal Investigator: Bettina Kinge, MD DMSc Aleris Helse, Oslo
  More Information

Responsible Party: Bettina Kinge ( Aleris Helse, Oslo, Norway )
Study ID Numbers: ROCC study 2007
Study First Received: December 3, 2007
Last Updated: December 4, 2007
ClinicalTrials.gov Identifier: NCT00567697  
Health Authority: Norway: The National Committees for Research Ethics in Norway

Keywords provided by Aleris Helse:
ranibizumab
CRVO
macular edema
sham

Study placed in the following topic categories:
Eye Diseases
Vascular Diseases
Retinal Degeneration
Edema
Macular Degeneration
Thrombosis
Macular Edema
Signs and Symptoms
Methamphetamine
Embolism and Thrombosis
Embolism
Retinal Vein Occlusion
Neoplasm Metastasis
Amphetamine
Venous Thrombosis
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009