Back to results

Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions (LVO)

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Intravitreal injection of ranibizumab .3 dose

Intravitreal injection of Ranibizumab .5 dose

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring vein occlusion, macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
- Renal failure requiring dialysis or renal transplant
- Premenopausal women not using adequate contraception
- Previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months

Sites / Locations

Wilmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

RBZ 0.3

RBZ 0.5

Arm Description

RBZ at the 0.3 mg dose intravitreal injection

RBZ dose level .5 for ITV injection

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity Change From Baseline at All Visits

Retinal Thickness Change From Baseline at All Visits

Secondary Outcome Measures

Full Information

NCT ID

NCT00407355

First Posted

December 1, 2006

Last Updated

October 7, 2013

Sponsor

Peter A Campochiaro, MD

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00407355

Brief Title

Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions

Acronym

LVO

Official Title

A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects With Macular Edema Secondary to Vein Occlusions.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter A Campochiaro, MD

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study is a phase II, open-label study to investigate the bioactivity and pharmacodynamics of intravitreous ranibizumab in subjects with macular edema due to central and branch retinal vein occlusion. This pilot study will enroll 40 patients, 20 with central vein occlusion and 20 with branch vein occlusion. Each patient will receive three (3) injections of 0.5 or 0.3 mg of ranibizumab. The study consists of a 2-week screening period (Days -14 to -1), a 3-month treatment period, and a 9-month follow-up period. Consented subjects will enter the 14-day screening period to determine eligibility, including serum chemistry and hematology testing, urinalysis, pregnancy testing, and macular thickness based on optical coherence tomography measurements and fluorescein angiography. Patients who have reduction of visual acuity to 20/40 or worse due to foveal thickening from macular edema secondary to central or branch retinal vein occlusion and who meet eligibility criteria will be invited to enroll in the study. Baseline foveal thickness by OCT must be at least 250 um, which is often associated with VA of 20/40 or worse and provides sufficient thickening so that a treatment effect is easily detectable (Nguyen et al. 2004). Every effort will be made to recruit and enroll eligible patients from men and women of all ethnic and social backgrounds. It is expected that the 40 study subjects will be recruited over a 4-month period. Patients who meet entry criteria will be able to enroll in the study until the quota of patients has been achieved. All enrolled patients will receive either 0.5 or 0.3 mg injections of ranibizumab. Forty eligible subjects who have provided informed consent from one site (Wilmer Eye Institute at the Johns Hopkins Medical Institutions) will be enrolled, 20 with central vein occlusion and 20 with branch vein occlusion. In each of the 2 groups, 10 patients will be randomized to 0.5 mg of the ranibizumab, and 10 will be randomized to 0.3 mg of ranibizumab. Subjects will be identified and recruited through the clinic population of the Wilmer Eye Institute, including that of the Vitreoretinal Service and the Retinal Vascular Center, as well as through referral from physicians in the community. Announcement of the study will be made throughout the Wilmer Eye Institute, Johns Hopkins University School of Medicine through newsletters, pamphlets, and the clinical trials web site on the internet and intranet systems. Information about the study will also be sent to the community physicians as well as the ophthalmologists who often refer patients to the Wilmer Eye Institute. Every effort will be made to enroll eligible patients from men and women of all ethnic and social backgrounds.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema, Retinal Vein Occlusion

Keywords

vein occlusion, macular edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RBZ 0.3

Arm Type

Active Comparator

Arm Description

RBZ at the 0.3 mg dose intravitreal injection

Arm Title

RBZ 0.5

Arm Type

Active Comparator

Arm Description

RBZ dose level .5 for ITV injection

Intervention Type

Drug

Intervention Name(s)

Intravitreal injection of ranibizumab .3 dose

Intervention Description

PRN every 30 days withing retreatment criteria

Intervention Type

Drug

Intervention Name(s)

Intravitreal injection of Ranibizumab .5 dose

Intervention Description

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

Primary Outcome Measure Information:

Title

Best Corrected Visual Acuity Change From Baseline at All Visits

Time Frame

continuous through 72 mos

Title

Retinal Thickness Change From Baseline at All Visits

Time Frame

continuous through 72 mos

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Renal failure requiring dialysis or renal transplant Premenopausal women not using adequate contraception Previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter A Campochiaro, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wilmer Eye Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24053892

Citation

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.

Results Reference

derived

Learn more about this trial

Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions

We'll reach out to this number within 24 hrs