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OpenTrials
Completed

NCT Number: NCT00590694

Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Neovascular Macular Degeneration Pigment Epithelial Detachment Retinal Degeneration Retinal Detachment Retinal Diseases Wet Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pacific Eye Associates

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ranibizumab

Drug

0.5mg injection monthly according to protocol for one year

Other names: Lucentis injection

Primary outcomes

  1. Mean change in visual acuity from baseline over 12 months

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pacific Eye Associates

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Acronym: DETAIL

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 11, 2008
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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