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

This study has been completed.
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
Bay Area Retina Associates
ClinicalTrials.gov Identifier:
NCT00390208
First received: October 17, 2006
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: ranibizumab, dexamethasone and verteporfin
Drug: Ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bay Area Retina Associates:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lesion size [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Lesion leakage [ Time Frame: one year ] [ Designated as safety issue: No ]
  • OCT measurement of macular thickness, subretinal fluid and cystoid edema [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Total number of treatments required [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Timing of visual improvement after initiation of therapy [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Combination triple therapy of Lucentis, Dexamethasone and Visudyne Therapy
Drug: ranibizumab, dexamethasone and verteporfin
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.
Group 2
Monotherapy: One 0.5 mg intravitreal Ranibizumab injection
Drug: Ranibizumab
One 0.5 mg intravitreal Ranibizumab injection

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390208

Locations
United States, California
Bay Area Retina Associates
Castro Valley, California, United States, 94546
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Georgia
Georgia Retina
Riverdale, Georgia, United States, 30274
United States, Ohio
Retina Vitreous Associates
Toledo, Ohio, United States, 43608
Sponsors and Collaborators
Bay Area Retina Associates
QLT Inc.
Investigators
Principal Investigator: Subhransu K Ray, M.D., Ph.D. Bay Area Retina Associates
  More Information

Additional Information:
Publications:

Responsible Party: Subhransu K. Ray, M.D., Ph.D., Bay Area Retina Associates
ClinicalTrials.gov Identifier: NCT00390208     History of Changes
Other Study ID Numbers: PDEX
Study First Received: October 17, 2006
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bay Area Retina Associates:
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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Verteporfin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 20, 2014