Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion

NCT01028248 | Completed Phase 1 DMC

• 1 other identifier: FVF4714s
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether ranibizumab (Lucentis) 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

Keywords

Central Retinal Vein Occlusion; Retinal Vein Occlusive disease

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be mean change from baseline best-corrected visual acuity, at Months 6 and 12, based on ETDRS visual acuity chart assessment starting distance of 4 meters.

  6 months and 12 months

Secondary Outcomes (3)

• Mean number of treatments up to and including Month 6 and 12 for each group (0.5-mg and 2.0-mg).

  6 months, 12 months

• Mean change from baseline in center point thickness, central 1mm subfield thickness and total macular volume over time as measured as assessed by spectral-domain or fourier-domain OCT up to Month 12.

  12 months

• To determine if changes in mean best-corrected visual acuity are correlated with changes in total macular volume, center point thickness, and/or central 1mm subfield thickness.

  Baseline to 12 months

Study Arms (2)

2.0 mg Ranibizumab

ACTIVE COMPARATOR

Drug: Ranibizumab (Lucentis)

0.5 mg Ranibizumab

ACTIVE COMPARATOR

Drug: Ranibizumab (Lucentis)

Interventions

Ranibizumab (Lucentis) DRUG

0.5mg and 2.0mg dose of Ranibizumab 0.05ml administered intravitreally

0.5 mg Ranibizumab; 2.0 mg Ranibizumab

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 and/or central 1mm subfield 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 pre-menopausal women not using adequate contraception.
• Participation in another ocular investigation or trial simultaneously
• Uncontrolled hypertension
• Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
• Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
• Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema
• An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of 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 (e.g. AMD, uveitis, Irvine-Gas)
• Evidence of neovascularization of the iris or retina (presence of ischemic CRVO)
• Evidence of central atrophy or fibrosis in the study eye
• 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.

Sponsors & Collaborators

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

Study Sites (3)

California Retina Consultants

Bakersfield, California, 93309, 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, MD

  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: December 7, 2009
• First Posted: December 9, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (3)