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

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
Pacific Eye Associates Identifier:
First received: December 26, 2007
Last updated: April 10, 2012
Last verified: April 2012
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
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:

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 ]

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

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


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00590694

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

Additional Information:
Responsible Party: Pacific Eye Associates 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

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

Additional relevant MeSH terms:
Macular Degeneration
Dissociative Disorders
Retinal Detachment
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on May 22, 2017