Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring Hemorrhagic Choroidal Neovascularization

Eligibility Criteria

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

Inclusion Criteria: Subjects will be eligible if the following criteria are met: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse. Age greater than 50 years. Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: Known hypersensitivity to humanized monoclonal antibodies History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment). History of stroke within 6 months of study entry. Current acute ocular or periocular infection. Any major surgical procedure within one month of study entry. Known serious allergies to fluorescein dye. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months. History of subfoveal laser treatment in the study eye. History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye. Ocular inflammation (including trace or above) in the study eye. Inability to comply with study or follow up procedures.

Sites / Locations

The Wilmer Eye Institute at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A

B

Arm Description

0.3 mg/0.05 ml dose of ranibizumab

0.5 mg/0.05 ml dose of ranibizumab

Outcomes

Primary Outcome Measures

Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.

Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.

Secondary Outcome Measures

Retinal Changes on Funduscopy

Retinal Thickness Measured by Optical Coherence Tomography (OCT)

Fluorescein Leakage on Fluorescein Angiography

Number of Subjects Experiencing Complications Related to Drug or Its Administration

Potential complications included: Deterioration of best-corrected visual acuity by 3 or more lines Development of intraocular inflammation Development of elevated intraocular pressure Development of other ocular or systemic adverse effects. Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function.

Full Information

NCT ID

NCT00363168

First Posted

August 9, 2006

Last Updated

September 18, 2012

Sponsor

Johns Hopkins University

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00363168

Brief Title

Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Official Title

Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration. A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.

Detailed Description

This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness <225 microns).

6. Conditions and Keywords

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

Choroidal Neovascularization

Keywords

Hemorrhagic Choroidal Neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Description

0.3 mg/0.05 ml dose of ranibizumab

Arm Title

B

Arm Type

Experimental

Arm Description

0.5 mg/0.05 ml dose of ranibizumab

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

0.3 mg/0.05 ml dose

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

0.5 mg/0.05 ml dose

Primary Outcome Measure Information:

Title

Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.

Description

Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Retinal Changes on Funduscopy

Time Frame

12 months

Title

Retinal Thickness Measured by Optical Coherence Tomography (OCT)

Time Frame

12 months

Title

Fluorescein Leakage on Fluorescein Angiography

Time Frame

12 months

Title

Number of Subjects Experiencing Complications Related to Drug or Its Administration

Description

Potential complications included: Deterioration of best-corrected visual acuity by 3 or more lines Development of intraocular inflammation Development of elevated intraocular pressure Development of other ocular or systemic adverse effects. Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function.

Time Frame

12 months after last injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Subjects will be eligible if the following criteria are met: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse. Age greater than 50 years. Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: Known hypersensitivity to humanized monoclonal antibodies History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment). History of stroke within 6 months of study entry. Current acute ocular or periocular infection. Any major surgical procedure within one month of study entry. Known serious allergies to fluorescein dye. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months. History of subfoveal laser treatment in the study eye. History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye. Ocular inflammation (including trace or above) in the study eye. Inability to comply with study or follow up procedures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil M. Bressler, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Wilmer Eye Institute at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20827138

Citation

Chang MA, Do DV, Bressler SB, Cassard SD, Gower EW, Bressler NM. Prospective one-year study of ranibizumab for predominantly hemorrhagic choroidal neovascular lesions in age-related macular degeneration. Retina. 2010 Sep;30(8):1171-6. doi: 10.1097/IAE.0b013e3181dd6d8a.

Results Reference

result

Choroidal Neovascularization

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial