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HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration

NCT01189019 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-29

No results posted yet for this study

Summary

In this fifth year of anti-VEGF therapy for neovascular AMD, retinal physicians are collecting groups of patients who either do not or only partially respond to anti-VEGF therapy. This study will evaluate the efficacy and safety of 2mg ranibizumab specifically for patients with fibrovascular PEDs that have not resolved following at least 6 consecutive injections of ranibizumab or bevacizumab over the previous 12 months. The investigators hypothesize that the 2mg dose will be able to completely eliminate the persistent PEDS in these patients.

Conditions

  • Wet Macular Degeneration
  • Macular Degeneration
  • Retinal Pigment Epithelial Detachment

Interventions

DRUG

ranibizumab

2mg intravitreal injection monthly

DRUG

ranibizumab

2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Anne Fung MD

    lead OTHER

Principal Investigators

  • Anne Fung, MD · Pacific Eye Associates / California Pacific Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01189019 on ClinicalTrials.gov