Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clement K. Chan, Southern California Desert Retina Consultants, MC
ClinicalTrials.gov Identifier:
NCT00749021
First received: September 8, 2008
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Retinal Pigment Epithelial Detachment
Drug: Ranibizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Efficacy and Safety of Treating Subfoveal Pigment Epithelial Detachment Associated With Choroidal Neovascularization With Anti-vascular Endothelial Growth Factor Fragment, Ranibizumab.

Resource links provided by NLM:


Further study details as provided by Southern California Desert Retina Consultants, MC:

Primary Outcome Measures:
  • Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of eyes reaching BCVA greater than or equal to 20/200 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of eyes gaining greater than or equal to 0, 5, 10, and 15 letters on the ETDRS chart [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reduction in central macular thickness from baseline (central 1-mm subfield) as measured by an OCT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in choroidal neovascular lesion (CNV)size on fluorescein angiography and fundus photography from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in retinal pigment epithelial detachment size on fluorescein angiography and fundus photography, including height of the PED and associated submacular fluid on OCT in comparison to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Status of fluorescein staining or leakage (increased or decreased) from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Ocular safety outcome including ocular complication, i.e. RPE tears, uveitis, endophthalmitis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Systemic safety outcome including cardiovascular event, cerebral vascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients with an improvement from baseline in Contrast Sensitivity at 24 and 48 weeks [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with an improvement from baseline in the VFQ overall composite score and near and distance activities subscales at 24 and 48 weeks [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regimen 1
Intravitreal injection of Ranibizumab monthly for 12 months.
Drug: Ranibizumab
0.5 mg of intravitreal ranibizumab monthly for 12 months
Other Name: Lucentis
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.
Drug: Ranibizumab
0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing
Other Name: Lucentis
Active Comparator: Regimen 3
Intravitreal injection of Ranibizumab 2.0mg monthly for 12 months
Drug: Ranibizumab
2.0mg of intravitreal ranibizumab monthly for 12 months
Other Name: Lucentis
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
Drug: Ranibizumab
2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is 50 years or older
  • Patient is willing to participate in this study and to follow the criteria and protocol of this study.
  • Patient is not involved with another clinical trial.
  • Ability to understand the informed consent and willingness to sign the consent.
  • Presence of a submacular vascularized or fibrovascular PED. Central foveal involvement by the PED or the CNV due to age related macular degeneration.
  • PED less than or equal to 12 disc area in size
  • BCVA with ETDRS of greater than or equal to 19 letters and less than or equal to 69 letters (20/400 to 20/40)
  • Central 1-mm foveal thickness of greater than or equal to 250 microns on OCT.
  • Greatest linear diameter of the submacular hemorrhage needs to be less than 50% of the entire PED.
  • Submacular fibrosis needs to be less than 50% of the entire PED.
  • Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA, and FP.
  • Intraocular pressure of 25 mm or less in the study eye, with or without use of ocular hypotensive agents.

Exclusion Criteria:

  • Pregnancy or lactation
  • Premenopausal women not using adequate contraception
  • Known serious allergies to ranibizumab, fluorescein dye, drug for pupillary dilation, topical anesthetic, sterilizing solution
  • Contraindication to pupillary dilation in study eye
  • Any condition (including inability to read visual acuity charts or language barrier) that may preclude patient's ability to comply with the study protocol requirements
  • Presence of any advanced systemic condition or endstage disease, advanced Alzheimer syndrome, endstage cancer, etc., which will likely prevent patient from completing study.
  • Previous therapeutic radiation in the region of the study eye.
  • Prior anti-vascular endothelial factor therapy within 30 days.
  • More than 3 sessions of prior anti-VEGF therapy.
  • More than 1 prior photodynamic therapy (PDT)
  • Prior triamcinolone in the past 6 months or dexamethasone in the past 1 month.
  • Prior retinal pigment epithelial (RPE) tear in study eye.
  • Prior ocular surgery (except YAG laser capsulotomy) for study eye within past 90 days.
  • Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months.
  • Prior therapy for AMD (except minerals and vitamins), including laser, within the past 30 days.
  • Prior intraocular or periocular corticosteroid therapy within the past 120 days
  • Prior vitrectomy
  • Presence of any causes of CNV and PED other than due to AMD.
  • Presence of any substantial ocular disease (other than CNV and PED) that may compromise vision in the study eye and/or confound interpretation of the date; e.g. substantial cataracts, concomitant diabetic retinopathy affecting the macula, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
  • Presence of ocular disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis syndrome, angioid streaks, pathologic myopia (spherical equivalent of greater than or equal to -8 diopters of myopia or axial length of greater than or equal to 25 mm), choroidal rupture, multifocal choroiditis, etc.
  • Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening or Day 0.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749021

Locations
United States, California
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
Southern California Desert Retina Consultants
Palm Desert, California, United States, 92211
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
Clement K. Chan
Investigators
Principal Investigator: Clement K Chan, M.D. Southern California Desert Retina Consultants
  More Information

No publications provided

Responsible Party: Clement K. Chan, Principal Investigator, Southern California Desert Retina Consultants, MC
ClinicalTrials.gov Identifier: NCT00749021     History of Changes
Other Study ID Numbers: FVF4332s
Study First Received: September 8, 2008
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Southern California Desert Retina Consultants, MC:
choroidal neovascularization
vascularized

Additional relevant MeSH terms:
Neovascularization, Pathologic
Retinal Detachment
Dissociative Disorders
Choroidal Neovascularization
Metaplasia
Pathologic Processes
Retinal Diseases
Eye Diseases
Mental Disorders
Choroid Diseases
Uveal Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014