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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 32
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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.
Sham Comparator: B 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567697

Locations
Norway
Bettina Kinge, Retinaklinikken Aleris
Oslo, Norway, 0264
Ingar Stene Johansen
Oslo, Norway
Vegard Forsaa
Stavanger, Norway
Kristian Fossen
Tromsø, Norway
Sponsors and Collaborators
Aleris Helse
Novartis
Investigators
Principal Investigator: Bettina Kinge, MD DMSc Aleris Helse, Oslo
  More Information

No publications provided by Aleris Helse

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aleris Helse
ClinicalTrials.gov Identifier: NCT00567697     History of Changes
Other Study ID Numbers: ROCC study 2007
Study First Received: December 3, 2007
Last Updated: January 18, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Aleris Helse:
ranibizumab
CRVO
macular edema
sham

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014