Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments

Conditions

• Retinal Pigment Epithelial Detachment

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  0.5 mg of intravitreal ranibizumab monthly for 12 months
• Ranibizumab — DRUG
  0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing
• Ranibizumab — DRUG
  2.0mg of intravitreal ranibizumab monthly for 12 months
• Ranibizumab — DRUG
  2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing

Study Details

This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.

Key Dates

First listed

Sep 9, 2008

Start date

Sep 30, 2008

Status verified

Oct 2012

Primary completion

Aug 31, 2012

Completion

Aug 31, 2012

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Regimen 1
  Intravitreal injection of Ranibizumab monthly for 12 months.
• Active Comparator: Regimen 2
  Intravitreal injection of ranibizumab for 4 months (at Day 0, Month 1, Month 2, and Month 3) followed by by treatments on predefined re-treatment criteria.
• Active Comparator: Regimen 3
  Intravitreal injection of Ranibizumab 2.0mg monthly for 12 months
• Active Comparator: Regimen 4
  Intravitreal injection 2.0mg ranibizumab for 4 months (at Day 0, Month 1 and Month 2, and Month 3) followed by PRN treatments on pre-defined re-treatment criteria

Primary Outcome Measure

Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months. [ Time Frame: 12 months ]

Locations (3)

Find similar trials in Los Angeles, CA