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Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Information source: Pacific Eye Associates
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Age-related Macular Degeneration; Pigment Epithelial Detachment; Neovascular Macular Degeneration; Wet Macular Degeneration

Intervention: ranibizumab (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Pacific Eye Associates

Official(s) and/or principal investigator(s):
Anne Fung, MD, Principal Investigator, Affiliation: Pacific Eye Associates / California Pacific Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean change in visual acuity from baseline over 12 months

Secondary outcome:

Time to OCT resolution of macular edema and pigment epithelial detachment

Proportion of patients with complete resolution of PED at 6 and 12 months

Durability of outcome: time from last ranibizumab injection to retreatment

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pacific Eye Associates, San Francisco, California 94115, United States
Additional Information

Pacific Eye Associates website

Related publications:

Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83.

Starting date: October 2006
Last updated: April 10, 2012

Page last updated: August 23, 2015

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