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Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lucentis
Ranibizumab
Ranibizumab (Lucentis)
Ranibizumab (Lucentis)
Sponsored by
The National Retina Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Macular Degeneration, Age Related Macular Degeneration, Retinal Angiomatous Proliferations

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age > 50 years
  • Definite characteristic signs of age related macular degeneration including drusen
  • Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion Criteria:

  • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
  • Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
  • Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
  • Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
  • History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Sites / Locations

  • National Retina Institute
  • National Retina Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Lucentis 0.3mg/0.05 ml

Lucentis 0.5mg/0.05 ml

Outcomes

Primary Outcome Measures

Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
Incidence and severity of ocular adverse events
Incidence and severity of non-ocular adverse events
Changes in vital signs

Secondary Outcome Measures

Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions
Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT
Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography
Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination

Full Information

First Posted
November 1, 2006
Last Updated
February 6, 2009
Sponsor
The National Retina Institute
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00395707
Brief Title
Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration
Official Title
Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The National Retina Institute
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.
Detailed Description
This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Macular Degeneration, Age Related Macular Degeneration, Retinal Angiomatous Proliferations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Lucentis 0.3mg/0.05 ml
Arm Title
2
Arm Type
Active Comparator
Arm Description
Lucentis 0.5mg/0.05 ml
Intervention Type
Drug
Intervention Name(s)
Lucentis
Other Intervention Name(s)
Ranibizumab
Intervention Description
0.3mg/0.05 ml or 0.5mg/0.05 ml
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.3mg/0.05 ml or 0.5mg/0.05 ml
Intervention Type
Drug
Intervention Name(s)
Ranibizumab (Lucentis)
Other Intervention Name(s)
Ranibizumab, Lucentis
Intervention Description
0.3mg/0.05 ml intravitreally
Intervention Type
Drug
Intervention Name(s)
Ranibizumab (Lucentis)
Other Intervention Name(s)
Ranibizumab, Lucentis
Intervention Description
0.5mg/0.05 ml
Primary Outcome Measure Information:
Title
Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
Time Frame
2 years
Title
Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
Time Frame
12 months
Title
Incidence and severity of ocular adverse events
Time Frame
12 months
Title
Incidence and severity of non-ocular adverse events
Time Frame
12 months
Title
Changes in vital signs
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions
Time Frame
12 months
Title
Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT
Time Frame
2 years
Title
Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography
Time Frame
2 years
Title
Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses
Time Frame
2 years
Title
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG
Time Frame
2 years
Title
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age > 50 years Definite characteristic signs of age related macular degeneration including drusen Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG) Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments) Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0 Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.) Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Johnson, MD
Organizational Affiliation
National Retina Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Retina Institute
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
National Retina Institute
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States

12. IPD Sharing Statement

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Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

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