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

Part of paid clinical trials in San Francisco, California.

Sponsor
Anne Fung MD
Study ID
NCT01189019
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ranibizumab — DRUG
    2mg intravitreal injection monthly
  • ranibizumab — DRUG
    2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT

Study Details

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.

Key Dates

First listed
Aug 26, 2010
Start date
Aug 31, 2010
Status verified
Mar 2016
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - 2mg ranibizumab monthly
    2mg ranibizumab monthly
  • Active Comparator: Group 2 - 2mg x 3 then PRN

Primary Outcome Measure

Mean change in visual acuity from baseline to 24 months [ Time Frame: 24 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Pacific Eye AssociatesSan FranciscoCalifornia94115-
Retina Associates of KentuckyLexingtonKentucky40509-
Tennessee RetinaNashvilleTennessee37203-

Find similar trials in San Francisco, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Pacific Eye Associates· San Francisco, CARetina Associates of Kentucky· Lexington, KYTennessee Retina· Nashville, TN

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