Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

Allergan

Status and phase: Terminated; Phase 2

Conditions: Age-Related Maculopathy; Subfoveal Choroidal Neovascularization

Treatments: Drug: 700 ug dexamethasone; Biological: ranibizumab; Other: sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122511

206207-021

Details and patient eligibility

About

This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration

Enrollment: 4 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
• Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
• Visual acuity between 20/320 and 20/40

Exclusion criteria

• Active ocular infection
• Contraindication to pupil dilation in either eye
• Eye surgery including cataract surgery and/or laser of any type within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

4 participants in 2 patient groups

700 ug dexamethasone and ranibizumab

Experimental group

Description:

Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye

Treatment:

Biological: ranibizumab

Drug: 700 ug dexamethasone

ranibizumab and sham

Active Comparator group

Description:

Intravitreal injection of ranibizumab and Sham into study eye

Treatment:

Biological: ranibizumab

Other: sham