Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

Retinal Vein Occlusion Clinical Trial

Official title:

Phase I Study of Intravitreally Administered Ranibizumab in 20 Subjects With Macular Edema Associated With CRVO.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403039
• Other study ID #: FVF3851S
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2006
• Last updated: December 31, 2015
• Start date: November 2006
• Est. completion date: December 2011

Study information

• Verified date: December 2015
• Source: Vitreous -Retina- Macula Consultants of New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab (Lucentis )

Locations

Country	Name	City	State
United States	Vitreous Retina Macula Consultants of New York, P.C.	New York City	New York

Sponsors (2)

Lead Sponsor	Collaborator
Vitreous -Retina- Macula Consultants of New York	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of Macular Edema associated with CRVO		72 months	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes