Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions

NCT00407355 | Completed Phase 1 Results

• 1 other identifier: 05-06-09-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Central and branch retinal vein occlusions are major causes of visual loss. Hemorrhage and capillary nonperfusion, when they involve the macula, can contribute to visual loss, but the major cause is macular edema. Focal and grid laser photocoagulation can sometimes provide benefit in patients with macular edema due to branch vein occlusions, but several laser treatments are often needed and recovery of vision can be very slow and incomplete 1. Laser photocoagulation does not provide benefit for macular edema due to central vein occlusions 2. Therefore, new treatments are needed.The objective of this study is to assess the bioactivity of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema due to central and branch retinal vein occlusions and correlate activity with peak and trough aqueous levels. The purpose of this research protocol is pilot study to determine if a randomized placebo controlled trial is warranted.

Conditions

Macular Edema; Retinal Vein Occlusion

Keywords

vein occlusion; macular edema

Outcome Measures

Primary Outcomes (2)

• Best Corrected Visual Acuity Change From Baseline at All Visits

  continuous through 72 mos

• Retinal Thickness Change From Baseline at All Visits

  continuous through 72 mos

Study Arms (2)

RBZ 0.3

ACTIVE COMPARATOR

RBZ at the 0.3 mg dose intravitreal injection

Drug: Intravitreal injection of ranibizumab .3 dose

RBZ 0.5

ACTIVE COMPARATOR

RBZ dose level .5 for ITV injection

Drug: Intravitreal injection of Ranibizumab .5 dose

Interventions

Intravitreal injection of ranibizumab .3 dose DRUG

PRN every 30 days withing retreatment criteria

RBZ 0.3

Intravitreal injection of Ranibizumab .5 dose DRUG

Intravitreal injection of Ranibizumab .5 dose every 30 days PRN with retreatment criteria

RBZ 0.5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent and authorization of use and disclosure of protected health information
• Age greater than or equal to 18 years
• Diagnosis of macular edema due to central or branch retinal vein occlusion
• Foveal thickness of over 250 um, as assessed by OCT
• Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity score in the non-study eye must be greater than 25 letters (approximate Snellen equivalent 20/320).
• In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
• In the opinion of the investigator, laser photocoagulation can be withheld for at least 30 days after the patient has enrolled in the study

You may not qualify if:

• Prior/Concomitant Treatment
• Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
• Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium \[EYE001\], ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 3 months of study entry Concurrent Ocular Conditions
• Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
• Ocular inflammation (including 1+ or above in the amount of cells) in the study eye
• History of idiopathic or autoimmune uveitis in either eye
• Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
• Ocular disorders in the study eye that may confound interpretation of study results, including diabetic retinopathy, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia)
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
• Intraocular surgery in the study eye within 3 months of study entry
• During the study, if patients need to have cataract surgery, the patients will undergo the necessary cataract or any other surgery and will continued to be treated per protocol and followed.
• Uncontrolled glaucoma (defined as intraocular pressure greater than 30 mm Hg despite treatment with anti-glaucoma medication) or previous filtration surgery in the study eye
• Infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection Systemic Conditions
• Blood pressure exceeding 160/95 (sitting) during the screening period

Sponsors & Collaborators

• Peter A Campochiaro, MD: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Sophie R, Hafiz G, Scott AW, Zimmer-Galler I, Nguyen QD, Ying H, Do DV, Solomon S, Sodhi A, Gehlbach P, Duh E, Baranano D, Campochiaro PA. Long-term outcomes in ranibizumab-treated patients with retinal vein occlusion; the role of progression of retinal nonperfusion. Am J Ophthalmol. 2013 Oct;156(4):693-705. doi: 10.1016/j.ajo.2013.05.039.

  PMID: 24053892 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Peter Campocahiro
• Organization: Wilmer Eye Institute

pcampo@jhmi.edu

: 410-955-5106

Study Officials

• Peter A Campochiaro, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 4, 2013
• Results First Posted: December 4, 2013

Record last verified: 2013-10

Locations

US (1)