A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Aleris Helse
ClinicalTrials.gov Identifier:
NCT00567697
First received: December 3, 2007
Last updated: January 18, 2012
Last verified: January 2012

December 3, 2007
January 18, 2012
March 2007
October 2008   (final data collection date for primary outcome measure)
The primary efficacy outcome measure is the mean change from baseline in BCVA score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00567697 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Central Retinal Vein Occlusion
  • Macular Edema
  • 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.
  • 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.
  • Active Comparator: A
    0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection
    Intervention: Drug: ranibizumab
  • Sham Comparator: B
    Intervention: Drug: ranibizumab
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. Epub 2010 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00567697
ROCC study 2007
Yes
Aleris Helse
Aleris Helse
Novartis
Principal Investigator: Bettina Kinge, MD DMSc Aleris Helse, Oslo
Aleris Helse
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP