Lucentis for Central Retinal Vein Occlusion (CRVO)

NCT00406796 | Completed Phase 1 DMC

• 1 other identifier: FVF3565s
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO).

Conditions

Central Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine the proportion of subjects in each group ( 0.3, 0.5 mg ) gaining 15 or more letters at month 6 and 12 (ETDRS visual refraction at 4 meters) and to determine if a difference exists between the high and low dose.

  6 and 12 months

Secondary Outcomes (6)

• To determine the safety and tolerability of ranibizumab in the treatment of macular edema associated with CRVO in each group

  6 and 12 months

• To determine the proportion of subjects in each group gaining 15 or more letters at month 3, 6, 9 & 12 as compared to baseline (ETDRS visual refraction at 4 meters) and to determine if a statistically significant difference exists between the groups

  3, 6, 9, and 12 months

• Change in central retinal thickness from baseline as measured by OCT at months 3, 6, 9 and 12

  3,6,9, and 12 months

• To determine the proportion of subjects in each group losing 15 or more letters at months 3,6,9,12 as compared to baseline (ETDRS visual refraction at 4 meters) and to determine if a statistically significant difference exists between the groups.

  3, 6, 9, and 12 months

• To determine the proportion of subjects in each group losing 30 or more letters at months 3,6,8,12 as compared to baseline (ETDRS visual refraction at 4 meters) and to determine if a statistically significant difference exists between the groups.

  3, 6, 9, and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

0.5mg Ranibizumab

Drug: Ranibizumab

2

ACTIVE COMPARATOR

0.3mg Ranibizumab

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

0.3mg and 0.5mg dose of Ranibizumab 0.05ml administered intravitreally

Also known as: Lucentis

1; 2

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age \> 18 years
• Clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.
• Central macular edema present on clinical examination and OCT testing with a central point thickness \> 250 microns
• Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
• Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

You may not qualify if:

• Pregnancy (positive pregnancy test) or known to be pregnant, also premenopausal women not using adequate contraception.
• Participation in another simultaneous ocular investigation or trial
• Patient with uncontrolled hypertension
• Patient has a condition that, in the opinion of the investigator would preclude participation in the study (i.e. chronic alcoholism, drug abuse)
• Patient has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
• Exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema
• Eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (i.e subretinal fibrosis or geographic atrophy)
• Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (i.e AMD, uveitis, Irvine-Gas)
• Evidence of neovascularization of the iris or retina (presence of ischemic CRVO)
• Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
• History of Grid/Focal laser or Panretinal laser in the study eye
• History of vitreous surgery in the study eye
• History of use of intravitreal, peribulbar, or retrobulbar steroids within six months of the study.
• History of Cataract Surgery within 6 months of enrollment.
• History of YAG capsulotomy within 2 months of the surgery.

Sponsors & Collaborators

• California Retina Consultants: lead
• Genentech, Inc.: collaborator

Study Sites (4)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

California Retina Consultants

Oxnard, California, 93030, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dante J Pieramici, M.D.

  California Retina Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: January 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2010
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (4)