A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD

Conditions

• Exudative Age-Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab and dexamethasone — DRUG
  Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection
• Ranibizumab — DRUG
  intravitreal injection of 0.5 mg ranibizumab

Study Details

The primary objective of this proposed research study is to evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alone in the treatment of wet ARMD. The addition of the broad spectrum anti-inflammatory activity of dexamethasone may augment the anti-VEGF activity of ranibizumab by amelioration of inflammation existing in the microenvironment of the choroidal neovascularization. While the anti-VEGF agents have proven to be very efficacious in the treatment of exudative ARMD, their narrow target and window of activity may limit their overall durability of action.

Key Dates

First listed

Nov 19, 2008

Start date

Jan 31, 2008

Status verified

Dec 2012

Primary completion

Jan 31, 2012

Completion

Dec 31, 2012

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Combination Therapy
  Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection
• Active Comparator: Monotherapy
  intravitreal injection of 0.5 mg ranibizumab

Primary Outcome Measure

Incidence and severity of ocular adverse events and visual acuity [ Time Frame: 6 months and 12 months ]

Locations (1)

Find similar trials in Walnut Creek, CA