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Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00403039
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York

Tracking Information
First Submitted Date  ICMJE November 22, 2006
First Posted Date  ICMJE November 23, 2006
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2006)
To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of Macular Edema associated with CRVO
Change History Complete list of historical versions of study NCT00403039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2006)
  • Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6 and 12
  • Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3, 6 and 12
  • Change in central retinal thickness as measured by OCT at months 3, 6, 9 and 12 compared to baseline
  • Proportion of subjects losing ≥ 30 letters as measured by ETDRS visual refraction at month 6 and 12
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema
Official Title  ICMJE Phase I Study of Intravitreally Administered Ranibizumab in 20 Subjects With Macular Edema Associated With CRVO.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinal Vein Occlusion
Intervention  ICMJE Drug: Ranibizumab (Lucentis )
Study Arms  ICMJE Open-label ranibizumab
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: Drug: Ranibizumab (Lucentis )
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 31, 2015)
41
Original Enrollment  ICMJE
 (submitted: November 22, 2006)
20
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00403039
Other Study ID Numbers  ICMJE FVF3851S
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vitreous -Retina- Macula Consultants of New York
Study Sponsor  ICMJE Vitreous -Retina- Macula Consultants of New York
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Richard F. Spaide, M.D. Vitreous Retina Macula Consultants of New York, P.C.
PRS Account Vitreous -Retina- Macula Consultants of New York
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP