A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01277302
First received: January 13, 2011
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

This study is a Phase IV multicenter randomized open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).


Condition Intervention Phase
Macular Edema
Drug: ranibizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Trend of change from baseline in BCVA score from Month 7 through Month 15 [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who gain at least 15 letters in best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) score [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with a BCVA Snellen equivalent of 20/40 or better [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in BCVA ETDRS score [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Proportion of subjects who lose fewer than 15 letters in BCVA ETDRS score [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: February 2011
Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: ranibizumab
Randomized as needed ranibizumab 0.5 mg injection
Experimental: B Drug: ranibizumab
Randomized monthly ranibizumab 0.5 mg injection
Experimental: C Drug: ranibizumab
Non-randomized monthly ranibizumab 0.5 mg injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study

Ocular Inclusion Criteria (Study Eye)

  • Foveal center-involved macular edema secondary to BRVO (including HRVO) or CRVO
  • BCVA using ETDRS charts of 20/40 to 20/320 (Snellen equivalent) in the study eye

Exclusion Criteria:

  • History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0
  • History of any systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 0
  • History of allergy to fluorescein
  • History of allergy to ranibizumab injection or related molecule
  • Relevant systemic disease that may be associated with increased systemic VEGF levels. History of successfully treated malignancies is not an exclusion criterion.
  • Uncontrolled blood pressure
  • Pregnancy or lactation
  • Daily use of oral corticosteroids to treat a chronic condition
  • Required treatment with injectable corticosteroids to treat a musculoskeletal condition
  • Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug or device that has not received regulatory approval at the time of study entry.

Ocular Exclusion Criteria (Study Eye)

  • Prior episode of retinal vein occlusion (RVO)
  • Brisk afferent pupillary defect
  • History of any previous intravitreal anti-VEGF therapy for RVO in the study eye
  • History of previous therapeutic treatment for RVO, other than anti-VEGF therapy, within 4 months prior to Day 0, including any intraocular corticosteroids
  • History of previous surgical treatment for RVO, including radial optic neurotomy or sheathotomy
  • History or presence of age-related macular degeneration (AMD) (dry or wet form)
  • History of laser photocoagulation for macular edema within 4 months prior to Day 0
  • History of panretinal scatter photocoagulation or sector laser photocoagulation within 4 months prior to Day 0 or anticipated within the next 4 months following Day 0
  • History of pars plana vitrectomy
  • History of intraocular surgery within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0
  • History of yttrium-aluminum-garnet (YAG) capsulotomy performed within 2 months prior to Day 0
  • Previous filtration surgery in the study eye
  • History of herpetic ocular infection
  • History of ocular toxoplasmosis
  • History of rhegmatogenous retinal detachment
  • History of idiopathic central serous chorioretinopathy
  • Evidence upon examination of vitreoretinal interface disease either on clinical examination or SD-OCT, thought to be contributing to macular edema
  • Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study
  • Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity. The subject should be followed and when the hemorrhage in the fovea clears to the point that it is no longer a major contributor to reduced visual acuity, the subject may be screened for the study.
  • Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
  • IOP >= 30 mmHg. If a subject's IOP is >= 30 mmHg, that subject will be referred for glaucoma treatment and may be re-screened after 1 month.
  • Evidence upon examination of pseudoexfoliation
  • Aphakia
  • Evidence upon examination of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
  • Evidence upon examination of any diabetic retinopathy, defined as eyes of diabetic patients with more than one microaneurysm outside the area of the vein occlusion (inclusive of both eyes)
  • Other relevant ocular disease that may be associated with increased intraocular VEGF levels
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277302

  Show 42 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Gary Sternberg, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01277302     History of Changes
Other Study ID Numbers: FVF4967g, ML01296
Study First Received: January 13, 2011
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 20, 2014