Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Age-related Macular Degeneration Clinical Trial

— DETAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590694
• Other study ID #: DETAIL Study for PED in AMD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 26, 2007
• Last updated: April 10, 2012
• Start date: October 2006
• Est. completion date: December 2009

Study information

• Verified date: April 2012
• Source: Pacific Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration
• Neovascular Macular Degeneration
• Pigment Epithelial Detachment
• Retinal Detachment
• Wet Macular Degeneration

Intervention

Drug:
• ranibizumab
0.5mg injection monthly according to protocol for one year

Locations

Country	Name	City	State
United States	Pacific Eye Associates	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Pacific Eye Associates	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in visual acuity from baseline over 12 months		12 months	No
Secondary	Time to OCT resolution of macular edema and pigment epithelial detachment		One year	No
Secondary	Proportion of patients with complete resolution of PED at 6 and 12 months		12 months	No
Secondary	Durability of outcome: time from last ranibizumab injection to retreatment		One year	No

External Links

•   Pacific Eye Associates website