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

NCT00567697 | Completed Phase 3 DMC

• 1 other identifier: ROCC study 2007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Central Retinal Vein Occlusion; Macular Edema

Keywords

ranibizumab; CRVO; macular edema; sham

Outcome Measures

Primary Outcomes (1)

• The primary efficacy outcome measure is the mean change from baseline in BCVA score

  6 months

Secondary Outcomes (1)

• Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale.

  6 months

Study Arms (2)

A

ACTIVE COMPARATOR

0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection

Drug: ranibizumab

B

SHAM COMPARATOR

Drug: ranibizumab

Interventions

ranibizumab DRUG

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.

A

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aleris Helse: lead
• Novartis: collaborator

Study Sites (4)

Bettina Kinge, Retinaklinikken Aleris

Oslo, 0264, Norway

Location

Ingar Stene Johansen

Oslo, Norway

Location

Vegard Forsaa

Stavanger, Norway

Location

Kristian Fossen

Tromsø, Norway

Location

Related Publications (1)

• 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.

  PMID: 20591399 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bettina Kinge, MD DMSc

  Aleris Helse, Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

NO (4)