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Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments (DETAIL)

Primary Purpose

Age-related Macular Degeneration, Pigment Epithelial Detachment, Neovascular Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Pacific Eye Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring ranibizumab, Lucentis, Pigment Epithelial Detachment, Macular Degeneration, PrONTO

Eligibility Criteria

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

Inclusion Criteria:

  • Neovascular age-related macular degeneration patients over age 50
  • Presence of a pigment epithelial detachment on optical coherence tomography
  • Initial or recurrent disease
  • Previous treatment allowed
  • Visual acuity between Snellen 20/40 - 20/400

Exclusion Criteria:

  • More than three previous treatments with PDT or other radiation/laser therapy
  • Previous vitrectomy or other AMD surgical intervention
  • Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)

Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.

Sites / Locations

  • Pacific Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group1

Group 2

Arm Description

Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.

Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.

Outcomes

Primary Outcome Measures

Mean change in visual acuity from baseline over 12 months

Secondary Outcome Measures

Time to OCT resolution of macular edema and pigment epithelial detachment
Proportion of patients with complete resolution of PED at 6 and 12 months
Durability of outcome: time from last ranibizumab injection to retreatment

Full Information

First Posted
December 26, 2007
Last Updated
April 10, 2012
Sponsor
Pacific Eye Associates
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00590694
Brief Title
Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Acronym
DETAIL
Official Title
Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacific Eye Associates
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Pigment Epithelial Detachment, Neovascular Macular Degeneration, Wet Macular Degeneration
Keywords
ranibizumab, Lucentis, Pigment Epithelial Detachment, Macular Degeneration, PrONTO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group1
Arm Type
Active Comparator
Arm Description
Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis injection
Intervention Description
0.5mg injection monthly according to protocol for one year
Primary Outcome Measure Information:
Title
Mean change in visual acuity from baseline over 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to OCT resolution of macular edema and pigment epithelial detachment
Time Frame
One year
Title
Proportion of patients with complete resolution of PED at 6 and 12 months
Time Frame
12 months
Title
Durability of outcome: time from last ranibizumab injection to retreatment
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neovascular age-related macular degeneration patients over age 50 Presence of a pigment epithelial detachment on optical coherence tomography Initial or recurrent disease Previous treatment allowed Visual acuity between Snellen 20/40 - 20/400 Exclusion Criteria: More than three previous treatments with PDT or other radiation/laser therapy Previous vitrectomy or other AMD surgical intervention Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma) Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Fung, MD
Organizational Affiliation
Pacific Eye Associates / California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Eye Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17386270
Citation
Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028.
Results Reference
background
Links:
URL
http://www.pacificeye.com/
Description
Pacific Eye Associates website

Learn more about this trial

Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

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