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Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration (PDEX)

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ranibizumab, dexamethasone and verteporfin
Ranibizumab
Sponsored by
Bay Area Retina Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Macular Degeneration, Degenerative changes in the macula lutea of the retina., Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related, RETINAL DEGENERATION, ARMD, AMD, Lucentis, Visudyne, Photodynamic Therapy, Verteporfin, Ranibizumab, Intravitreal Dexamethasone

Eligibility Criteria

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

Inclusion Criteria:

  • Best Corrected Visual Acuity 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 classic:
  • Classic lesion greater than 50% of the total lesion area

  • Lesion must be less than 12 disc areas

    • Minimally classic or occult:
  • CNVM must be greater than or equal to 50% of the total lesion size.
  • There must be some evidence of recent disease progression (heme, vision loss, recent lesion growth on FA)

  • Lesion size must be less than 12 disc areas.

    • Occult:
  • Lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid
  • Less than 12 disc areas in total size
  • Signed informed consent
  • Age greater than or equal to 50 years

Exclusion Criteria:

  • Pigment epithelial detachment greater than 50% of the total lesion size
  • Previous treatment for ARMD in the study eye
  • Previous intravitreal drug delivery in the study eye
  • History of 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 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
  • Inability to comply with study or follow up procedures

Sites / Locations

  • Bay Area Retina Associates
  • Bay Area Retina Associates
  • Georgia Retina
  • Retina Vitreous Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

Combination triple therapy of Lucentis, Dexamethasone and Visudyne Therapy

Monotherapy: One 0.5 mg intravitreal Ranibizumab injection

Outcomes

Primary Outcome Measures

Visual Acuity: Change in visual acuity by 15 or more ETDRS letters at 6 and 12 months. Non-inferiority as compared to the triple therapy arm will serve to determine efficacy for the purposes of this pilot trial.

Secondary Outcome Measures

Lesion size
Lesion leakage
OCT measurement of macular thickness, subretinal fluid and cystoid edema
Total number of treatments required
Timing of visual improvement after initiation of therapy

Full Information

First Posted
October 17, 2006
Last Updated
May 25, 2010
Sponsor
Bay Area Retina Associates
Collaborators
QLT Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00390208
Brief Title
Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration
Acronym
PDEX
Official Title
A Prospective Masked Pilot Study Comparing Group 1 Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Group 2 Monotherapy - Intravitreal Ranibizumab Alone.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bay Area Retina Associates
Collaborators
QLT Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare triple therapy using Photodynamic therapy, intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with intravitreal Ranibizumab alone for the treatment of Age-Related Macular Degeneration.
Detailed Description
This is a twelve month Phase II prospective masked study comparing Group 1 triple therapy: Same day combination therapy with PDT, 500 microgram dose (0.05cc) intravitreal dexamethasone injection (10mg/ml vial), and a single 0.5 mg intravitreal Ranibizumab injection. This will be compared to Group 2 monotherapy: one intravitreal injection of 0.5 mg Lucentis given every four weeks on a set dosing schedule. Sixty consecutive patients will be enrolled into this clinical trial utilizing the current standard of care guidelines as used at Bay Area Retina Associates. Angiography, fundus photography will be performed at the initial visit and quarterly follow-up visits. Only OCT testing will be performed at all other follow-up visits. Both groups will be re-evaluated for safety at 12 and 24 months. Group 1 Following the initial treatment, all future re-treatments with Lucentis will be determined on a PRN basis. The decision will be based on clinical examination and imaging evidence of lesion activity. Any evidence of subretinal fluid or cystoid edema on OCT or clinical examination, or evidence of leakage on angiogram will result in re-treatment. If after three consecutive Ranibizumab injections in Group 1, there is any evidence of lesion recurrence or growth of the neovascular membrane associated with visual decline or persistent subretinal fluid, the patient will be treated with repeat PDT/IVD/Lucentis The decision to retreat Group 1 with ranibizumab at each monthly follow-up visit will be dependent on clinical exam, OCT measurements or angiographic findings as documented below. Group 2 Subjects will receive one intravitreal injection of 0.5 mg Lucentis every four weeks until week 48 or as indicated on the FDA approval label.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Macular Degeneration, Degenerative changes in the macula lutea of the retina., Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related, RETINAL DEGENERATION, ARMD, AMD, Lucentis, Visudyne, Photodynamic Therapy, Verteporfin, Ranibizumab, Intravitreal Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Combination triple therapy of Lucentis, Dexamethasone and Visudyne Therapy
Arm Title
Group 2
Arm Type
Other
Arm Description
Monotherapy: One 0.5 mg intravitreal Ranibizumab injection
Intervention Type
Drug
Intervention Name(s)
ranibizumab, dexamethasone and verteporfin
Intervention Description
One 500 microgram dose (0.05cc) intravitreal dexamethasone (10 mg/ml vial) in combination with Visudyne Photodynamic Therapy and 0.5 mg intravitreal Ranibizumab injection on the same day.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
One 0.5 mg intravitreal Ranibizumab injection
Primary Outcome Measure Information:
Title
Visual Acuity: Change in visual acuity by 15 or more ETDRS letters at 6 and 12 months. Non-inferiority as compared to the triple therapy arm will serve to determine efficacy for the purposes of this pilot trial.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Lesion size
Time Frame
one year
Title
Lesion leakage
Time Frame
one year
Title
OCT measurement of macular thickness, subretinal fluid and cystoid edema
Time Frame
one year
Title
Total number of treatments required
Time Frame
one year
Title
Timing of visual improvement after initiation of therapy
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Best Corrected Visual Acuity 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 classic: Classic lesion greater than 50% of the total lesion area Lesion must be less than 12 disc areas Minimally classic or occult: CNVM must be greater than or equal to 50% of the total lesion size. There must be some evidence of recent disease progression (heme, vision loss, recent lesion growth on FA) Lesion size must be less than 12 disc areas. Occult: Lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid Less than 12 disc areas in total size Signed informed consent Age greater than or equal to 50 years Exclusion Criteria: Pigment epithelial detachment greater than 50% of the total lesion size Previous treatment for ARMD in the study eye Previous intravitreal drug delivery in the study eye History of 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 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 Inability to comply with study or follow up procedures
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
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Georgia Retina
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Retina Vitreous Associates
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://www.bayarearetina.com
Description
Study Sponsor website

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Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration

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