Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

NCT00403039 | Completed Phase 1

• 1 other identifier: FVF3851S
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema

Conditions

Retinal Vein Occlusion

Keywords

Central Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

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

  72 months

Secondary Outcomes (4)

• 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

  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.

  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

  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

  Months 6, 12, 24, 36, 48, 60 and 72

Study Arms (1)

Open-label ranibizumab

OTHER

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.

Drug: Ranibizumab (Lucentis )

Interventions

Ranibizumab (Lucentis ) DRUG

Open-label ranibizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), 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 \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitreous -Retina- Macula Consultants of New York: lead
• Genentech, Inc.: collaborator

Study Sites (1)

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

New York, New York, 10022, 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

• Richard F. Spaide, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2006
• First Posted: November 23, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

US (1)