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Lucentis for Central Retinal Vein Occlusion (CRVO)

Primary Purpose

Central Retinal Vein Occlusion

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion

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 > 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 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.
Visual acuity <20/400 in the fellow eye
Uncontrolled Glaucoma, pressure >30 despite treatment with glaucoma medications.

Sites / Locations

California Retina Consultants
California Retina Consultants
California Retina Consultants
California Retina Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

0.5mg Ranibizumab

0.3mg Ranibizumab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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.

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.

To determine if changes in 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

NCT00406796

First Posted

November 29, 2006

Last Updated

December 10, 2013

Sponsor

California Retina Consultants

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00406796

Brief Title

Lucentis for Central Retinal Vein Occlusion (CRVO)

Official Title

FVF3565s Intravitreal Ranibizumab (rhuFab V2) in the Treatment of Macular Edema Associated With Perfused Central (CRVO) Retinal Venous Occlusive Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

October 2010 (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 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 abd hemi vein occlusions. Currently, there is no proven treatment to address macular edema in these patients. 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. Investigators have demonstrated in case reports that intravitreal triamcinolone (Kenalog) may result in the reduction in macular edema, leading to visual improvement in some patients with CRVO. Triamcinolone is relatively well tolerated in many patients, but its use is associated with significant risk of elevated intraocular pressure, cataract, and intraocular infection. 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 triamcinolone

6. Conditions and Keywords

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

Central Retinal Vein Occlusion

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

Arm Type

Active Comparator

Arm Description

0.5mg Ranibizumab

Arm Title

Arm Type

Active Comparator

Arm Description

0.3mg Ranibizumab

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

6 and 12 months

Secondary Outcome Measure Information:

Title

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

Time Frame

6 and 12 months

Title

Time Frame

3, 6, 9, and 12 months

Title

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

Time Frame

3,6,9, and 12 months

Title

Time Frame

3, 6, 9, and 12 months

Title

Time Frame

3, 6, 9, and 12 months

Title

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

Time Frame

Months 1-12

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 > 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 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. Visual acuity <20/400 in the fellow eye Uncontrolled Glaucoma, pressure >30 despite treatment with glaucoma medications.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dante J Pieramici, M.D.

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

Oxnard

State/Province

California

ZIP/Postal Code

93030

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 Central Retinal Vein Occlusion (CRVO)

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