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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00590694
Other study ID # DETAIL Study for PED in AMD
Secondary ID
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


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
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