Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing

Conditions

• Persistent Diabetic Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  ranibizumab 0.3mg intravitreally monthly
• ranibizumab — DRUG
  ranibizumab given every 2 weeks for 8 weeks then monthly as needed

Study Details

The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.

Key Dates

First listed

May 1, 2014

Status verified

Jul 2014

Primary completion

Aug 31, 2015

Completion

Nov 30, 2015

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard Dosing Group
  Standard Dosing Group will receive intravitreal injections of 0.3mg. ranibizumab at baseline, week 4 and 8 )sham injections at week 2 and 6). After week 8 retreatment will be given monthly if edema is greater than 290um or ETDRS visual acuity score \<83
• Experimental: Frequent dosing group
  Frequent dosing subjects will be evaluated and treated every two weeks through week 8 with intravitreal injection of 0.3mg ranibizumab. Subjects will then be evaluated monthly through week 24 and will receive treatment with ranibiumab based on residual edema and visual acuity

Primary Outcome Measure

mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization [ Time Frame: 24 weeks ]

Locations (1)

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