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

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ClinicalTrials.gov Identifier: NCT00590694
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : April 12, 2012
Genentech, Inc.
Information provided by (Responsible Party):
Pacific Eye Associates

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis
Study Start Date : October 2006
Primary Completion Date : December 2009
Study Completion Date : December 2009

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 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

Primary Outcome Measures :
  1. Mean change in visual acuity from baseline over 12 months [ Time Frame: 12 months ]

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

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pacific Eye Associates
ClinicalTrials.gov Identifier: NCT00590694     History of Changes
Other Study ID Numbers: DETAIL Study for PED in AMD
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 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