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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Pacific Eye Associates
ClinicalTrials.gov Identifier:
NCT00590694
First received: December 26, 2007
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Age-related Macular Degeneration
Pigment Epithelial Detachment
Neovascular Macular Degeneration
Wet Macular Degeneration
 Drug: ranibizumab
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Pacific Eye Associates:

Primary Outcome Measures:
  • Mean change in visual acuity from baseline over 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to OCT resolution of macular edema and pigment epithelial detachment [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Proportion of patients with complete resolution of PED at 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Durability of outcome: time from last ranibizumab injection to retreatment [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lucentis injection

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590694

Locations
United States, California
Pacific Eye Associates
San Francisco, California, United States, 94115
Sponsors and Collaborators
Pacific Eye Associates
Genentech
Investigators
Principal Investigator: Anne Fung, MD Pacific Eye Associates / California Pacific Medical Center
  More Information

Additional Information:
Pacific Eye Associates website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Pacific Eye Associates
ClinicalTrials.gov Identifier: NCT00590694     History of Changes
Other Study ID Numbers: DETAIL Study for PED in AMD
Study First Received: December 26, 2007
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacific Eye Associates:
ranibizumab
Lucentis
Pigment Epithelial Detachment
Macular Degeneration
PrONTO

Additional relevant MeSH terms:
Macular Degeneration
Retinal Detachment
Dissociative Disorders
Wet Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013