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Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab (Lucentis )
Sponsored by
Vitreous -Retina- Macula Consultants of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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 34 letters (20/200) 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)
  • Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.
  • Evidence of neovascularization of the iris or retina (presence of ischemic CRVO)
  • 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.
  • Use of Bevacizumab in either eye within the past 30 days
  • Use of Pegaptinib sodium in either eye within the past 6 weeks
  • Use of Triamcinolone in either eye
  • Have received any other systemic experimental drug within 12 weeks prior to enrollment.
  • Unwilling or unable to follow or comply with all study related procedures.

Sites / Locations

  • Vitreous Retina Macula Consultants of New York, P.C.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-label ranibizumab

Arm Description

Subjects will receive open-label intravitreal injections of ranibizumab administered every 28 ± 7 days for a total of 3 injections. Thereafter they are to be evaluated monthly for re-treatment until Month 48.

Outcomes

Primary Outcome Measures

To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of Macular Edema associated with CRVO

Secondary Outcome Measures

Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6, 12, 24, 36, 48, 60 and 72
Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6, 12, 24, 36, 48, 60 and 72.
Change in central retinal thickness as measured by OCT at months 3, 6, 9, 12, 24, 36, 48, 60 and 72 compared to baseline
Proportion of subjects losing ≥ 30 letters as measured by ETDRS visual refraction at month 6, 12, 24, 36, 48, 60 and 72

Full Information

First Posted
November 22, 2006
Last Updated
December 31, 2015
Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00403039
Brief Title
Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema
Official Title
Phase I Study of Intravitreally Administered Ranibizumab in 20 Subjects With Macular Edema Associated With CRVO.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema
Detailed Description
This is an open-label, Phase I study of intravitreally administered ranibizumab in 20 subjects with macular edema associated with CRVO. Patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 ± 2 days for a total of 3 injections. Thereafter they are to be evaluated every month until month 12. If the patients have signs of increased intraretinal hemorrhage or a persistence / increase in central macular edema as determined by optical coherence tomography when compared to their last visit, are eligible for re-injection at that monthly visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
Central Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label ranibizumab
Arm Type
Other
Arm Description
Subjects will receive open-label intravitreal injections of ranibizumab administered every 28 ± 7 days for a total of 3 injections. Thereafter they are to be evaluated monthly for re-treatment until Month 48.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab (Lucentis )
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of Macular Edema associated with CRVO
Time Frame
72 months
Secondary Outcome Measure Information:
Title
Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6, 12, 24, 36, 48, 60 and 72
Time Frame
Months 3, 6, 12, 24, 36, 48, 60 and 72
Title
Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6, 12, 24, 36, 48, 60 and 72.
Time Frame
Months 3, 6, 12, 24, 36, 48, 60 and 72
Title
Change in central retinal thickness as measured by OCT at months 3, 6, 9, 12, 24, 36, 48, 60 and 72 compared to baseline
Time Frame
Months 3, 6, 12, 24, 36, 48, 60 and 72
Title
Proportion of subjects losing ≥ 30 letters as measured by ETDRS visual refraction at month 6, 12, 24, 36, 48, 60 and 72
Time Frame
Months 6, 12, 24, 36, 48, 60 and 72

10. Eligibility

Sex
All
Accepts Healthy Volunteers
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 34 letters (20/200) 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) Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc. Evidence of neovascularization of the iris or retina (presence of ischemic CRVO) 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. Use of Bevacizumab in either eye within the past 30 days Use of Pegaptinib sodium in either eye within the past 6 weeks Use of Triamcinolone in either eye Have received any other systemic experimental drug within 12 weeks prior to enrollment. Unwilling or unable to follow or comply with all study related procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard F. Spaide, M.D.
Organizational Affiliation
Vitreous Retina Macula Consultants of New York, P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitreous Retina Macula Consultants of New York, P.C.
City
New York City
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

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Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

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