Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Rocky Mountain Retina Consultants
Study ID
NCT00387582
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab (Lucentis) — DRUG
    Lucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.
  • Argon Laser — PROCEDURE
    Argon laser at entry to trial and then per protocol for the duration of the study.

Study Details

This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab (Lucentis) in the treatment of Diabetic Macular Edema as compared to grid/focal laser.

Key Dates

First listed
Oct 13, 2006
Start date
Jul 31, 2006
Status verified
May 2014
Primary completion
Feb 28, 2009
Completion
Feb 28, 2009

Study Design

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

Arms

  • Experimental: I
    Lucentis injections for the first three months of the study and then per the protocol for the duration of the trial.
  • Active Comparator: II
    Argon Laser treatment at enrollment and then per the protocol for the duration of the study.

Primary Outcome Measure

Prevention of vision loss at one year as evidenced by ETDRS visual acuity. [ Time Frame: 6 and 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Mountain Retina ConsultantsSalt Lake CityUtah84107-

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