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

Primary Purpose

Exudative Age-Related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab and dexamethasone
Ranibizumab
Sponsored by
Subhransu K. Ray, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Exudative Age-Related Macular Degeneration focused on measuring Exudative Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Best Corrected Visual Acuity at 4 meters using ETDRS Charts between 20/32 and 20/400 (Snellen Equivalent) in the study eye with evidence of neovascular ARMD.

(Only one eye will be eligible for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deems the other eye to be more appropriate for treatment and study.)

  • All lesion subtypes will be enrolled with the following criteria Predominantly and minimally classic: Angiographic lesion greater than 50% of the total lesion area Occult: Lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid
  • Signed informed consent
  • Age greater than or equal to 50 years

Exclusion Criteria:

  • Previous treatment for ARMD in the study eye
  • Previous intravitreal drug delivery in the study eye
  • Previous vitrectomy in the study eye
  • Fibrosis or atrophy involving the center of the fovea in the study eye
  • Neovascular membrane from any other concurrent retinal disease such as high myopia (SER > -8D), histoplasmosis or other ocular inflammatory disease.
  • Known history of glaucoma and on more than one topical medication
  • History of glaucoma filtering surgery in the study eye
  • History of corneal transplant in the study eye
  • Patients with active co-existing macular disease such as diabetic macular edema
  • Active intraocular inflammation in the study eye
  • History of allergy to fluorescein not amenable to treatment
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Inability to comply with study or follow up procedures
  • Participation in another simultaneous medical investigation or trial

Sites / Locations

  • Bay Area Retina Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination Therapy

Monotherapy

Arm Description

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

intravitreal injection of 0.5 mg ranibizumab

Outcomes

Primary Outcome Measures

Incidence and severity of ocular adverse events and visual acuity

Secondary Outcome Measures

Total number of treatments required

Full Information

First Posted
November 17, 2008
Last Updated
December 18, 2012
Sponsor
Subhransu K. Ray, M.D., Ph.D.
Collaborators
Bay Area Retina Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00793923
Brief Title
A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD
Acronym
Lucedex
Official Title
A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Subhransu K. Ray, M.D., Ph.D.
Collaborators
Bay Area Retina Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
A prospective, single masked comparative trial using either combination therapy (group 1): same day combination therapy with 0.05cc intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection for four consecutive months will be compared to monotherapy (group 2): one intravitreal injection of 0.5 mg ranibizumab also given for four consecutive months. These treatments will then be followed by PRN treatment based on clinical exam, angiographic studies, and OCT evidence of residual subretinal fluid, CME, subretinal hemorrhage, or pigment epithelial detachment. Fluorescein angiography and fundus photography will be performed at baseline and at the 1, 3, 6, and 12 month follow-up visits. Only OCT testing will be performed at all follow-up visits. Both groups will be re-evaluated for safety at 12 and 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-Related Macular Degeneration
Keywords
Exudative Age Related Macular Degeneration

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Monotherapy
Arm Type
Active Comparator
Arm Description
intravitreal injection of 0.5 mg ranibizumab
Intervention Type
Drug
Intervention Name(s)
ranibizumab and dexamethasone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
intravitreal injection of 0.5 mg ranibizumab
Primary Outcome Measure Information:
Title
Incidence and severity of ocular adverse events and visual acuity
Time Frame
6 months and 12 months
Secondary Outcome Measure Information:
Title
Total number of treatments required
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Best Corrected Visual Acuity at 4 meters using ETDRS Charts between 20/32 and 20/400 (Snellen Equivalent) in the study eye with evidence of neovascular ARMD. (Only one eye will be eligible for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deems the other eye to be more appropriate for treatment and study.) All lesion subtypes will be enrolled with the following criteria Predominantly and minimally classic: Angiographic lesion greater than 50% of the total lesion area Occult: Lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid Signed informed consent Age greater than or equal to 50 years Exclusion Criteria: Previous treatment for ARMD in the study eye Previous intravitreal drug delivery in the study eye Previous vitrectomy in the study eye Fibrosis or atrophy involving the center of the fovea in the study eye Neovascular membrane from any other concurrent retinal disease such as high myopia (SER > -8D), histoplasmosis or other ocular inflammatory disease. Known history of glaucoma and on more than one topical medication History of glaucoma filtering surgery in the study eye History of corneal transplant in the study eye Patients with active co-existing macular disease such as diabetic macular edema Active intraocular inflammation in the study eye History of allergy to fluorescein not amenable to treatment Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Inability to comply with study or follow up procedures Participation in another simultaneous medical investigation or trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhransu K Ray, M.D., Ph.D.
Organizational Affiliation
Bay Area Retina Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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