Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema - Full Text View

Sponsors and Collaborators:	Vitreous -Retina- Macula Consultants of New York Genentech
Information provided by:	Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:	NCT00403039

Purpose

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

Condition	Intervention	Phase
Retinal Vein Occlusion	Drug: Ranibizumab (Lucentis )	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Phase I Study of Intravitreally Administered Ranibizumab in 20 Subjects With Macular Edema Associated With CRVO.

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

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 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

Estimated Enrollment:	45
Study Start Date:	November 2006

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403039

Contacts

Contact: Peggy Guerrero	212-452-6965	pguerrero@vrmny.com
Contact: Richard Spaide, MD	212-861-9797

Locations

United States, New York
Vitreous Retina Macula Consultants of New York, P.C.	Recruiting
New York City, New York, United States, 10022
Contact: Peggy Guerrero 212-452-6965 pguerrero@vrmny.com
Contact: Richard Spaide, MD 212-861-9797
Principal Investigator: Richard F Spaide, M.D.

Sponsors and Collaborators

Vitreous -Retina- Macula Consultants of New York

Genentech

Investigators

Principal Investigator:

Richard F. Spaide, M.D.

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

More Information

No publications provided

Study ID Numbers:	FVF3851S
Study First Received:	November 22, 2006
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00403039 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vitreous -Retina- Macula Consultants of New York:

Central Retinal Vein Occlusion

Study placed in the following topic categories:

Macular Edema
Embolism and Thrombosis
Embolism
Eye Diseases
Retinal Vein Occlusion
Vascular Diseases

Retinal Degeneration
Macular Degeneration
Edema
Venous Thrombosis
Thrombosis
Retinal Diseases

Additional relevant MeSH terms:

Macular Edema
Embolism and Thrombosis
Eye Diseases
Retinal Vein Occlusion
Vascular Diseases
Retinal Degeneration

Macular Degeneration
Cardiovascular Diseases
Venous Thrombosis
Thrombosis
Retinal Diseases

ClinicalTrials.gov processed this record on July 02, 2009