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

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567697
• Other study ID #: ROCC study 2007
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2007
• Last updated: January 18, 2012
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2012
• Source: Aleris Helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

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.
• ranibizumab
Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.

Locations

Country	Name	City	State
Norway	Bettina Kinge, Retinaklinikken Aleris	Oslo
Norway	Ingar Stene Johansen	Oslo
Norway	Vegard Forsaa	Stavanger
Norway	Kristian Fossen	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
Aleris Helse	Novartis

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcome measure is the mean change from baseline in BCVA score		6 months	Yes
Secondary	Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale.		6 months	Yes