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Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion

Primary Purpose

Central Retinal Vein Occlusion

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ranibizumab (Lucentis)

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring Central Retinal Vein Occlusion, Retinal Vein Occlusive disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
History of YAG capsulotomy within 2 months of the surgery.
Visual acuity <20/400 in the fellow eye
Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.
History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.

Sites / Locations

California Retina Consultants
California Retina Consultants
California Retina Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

2.0 mg Ranibizumab

0.5 mg Ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

Full Information

NCT ID

NCT01028248

First Posted

December 7, 2009

Last Updated

December 10, 2013

Sponsor

California Retina Consultants

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01028248

Brief Title

Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion

Official Title

Phase I, Open-Label, Single-Center, Randomized, Study of the Safety and Efficacy of 0.5 mg and 2.0 mg Ranibizumab in Patients With Macular Edema Secondary to Perfused Central Retinal Vein Occlusion

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

California Retina Consultants

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Retinal Venous Occlusive disease is the second only to diabetic retinopathy as a major cause of blindness associated with retinal vascular disease. Macular edema is a major cause of vision loss in patients presenting with central and hemi vein occlusions. Until recently the standard of care for macular edema secondary to central retinal vein occlusion was observation. Recent investigations of steroids for this condition has shown greater visual benefit but is associated with risks such as cataract formation and increased intraocular pressure. In the past laser photocoagulation has been used, but was found to offer no visual benefits over the natural history in the treatment of macular edema associated with CRVO. Ranibizumab (rhuFab V2), an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Ranibizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to steroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Retinal Vein Occlusion

Keywords

Central Retinal Vein Occlusion, Retinal Vein Occlusive disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2.0 mg Ranibizumab

Arm Type

Active Comparator

Arm Title

0.5 mg Ranibizumab

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Ranibizumab (Lucentis)

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

6 months and 12 months

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months, 12 months

Title

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.

Time Frame

12 months

Title

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.

Time Frame

Baseline to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. History of YAG capsulotomy within 2 months of the surgery. Visual acuity <20/400 in the fellow eye Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications. History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dante J Pieramici, MD

Organizational Affiliation

California Retina Consultants

Official's Role

Principal Investigator

Facility Information:

Facility Name

California Retina Consultants

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

California Retina Consultants

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93103

Country

United States

Facility Name

California Retina Consultants

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

12. IPD Sharing Statement

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Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion

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