Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation

Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Study ID
NCT01223612
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection of 0.5mg in 0.05ml. One injection at baseline, 4 and 8 weeks then four-weekly as required to 44 weeks.
  • Modified ETDRS laser — PROCEDURE
    Argon laser therapy to the macula in accordance with the modified ETDRS protocol at baseline, 12, 24 and 36 weeks.

Study Details

This exploratory study will compare the effects of ranibizumab treatment with conventional macular laser therapy for patients with diabetic macular oedema. The study hypothesises that treatment with ranibizumab may be superior to laser treatment in terms of improving vision and decreasing retinal thickness. Patients will be randomised to receive either repeated injections of ranibizumab every 4 weeks for 48 weeks or macular laser therapy every 12 weeks for 48 weeks. At baseline, and then at 12, 24 and 48 weeks, patients will undergo detailed testing to provide information on the structure and function of the retina with both of these treatments.

Key Dates

First listed
Oct 19, 2010
Start date
Oct 31, 2010
Status verified
Sep 2020
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

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

Arms

  • Experimental: Ranibizumab
    Intravitreal injection of ranibizumab
  • Active Comparator: Laser
    Modified ETDRS laser

Primary Outcome Measure

Functional and anatomical change in the retina [ Time Frame: 48 weeks ]

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