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

April 10, 2012 updated by: Pacific Eye Associates

Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Pacific Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group1
Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.
Drug: ranibizumab
0.5mg injection monthly according to protocol for one year
Other Names:
  • Lucentis injection
Active Comparator: Group 2
Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.
Drug: ranibizumab
0.5mg injection monthly according to protocol for one year
Other Names:
  • Lucentis injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in visual acuity from baseline over 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Eye Associates

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DETAIL Study for PED in AMD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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