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

May 25, 2010 updated by: Bay Area Retina Associates

A Prospective Masked Pilot Study Comparing Group 1 Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Group 2 Monotherapy - Intravitreal Ranibizumab Alone.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Castro Valley, California, United States, 94546
        • Bay Area Retina Associates
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Georgia
      • Riverdale, Georgia, United States, 30274
        • Georgia Retina
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Retina Vitreous Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Group 2
Monotherapy: One 0.5 mg intravitreal Ranibizumab injection
Drug: Ranibizumab
One 0.5 mg intravitreal Ranibizumab injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Lesion size
Time Frame: one year
one year
Lesion leakage
Time Frame: one year
one year
OCT measurement of macular thickness, subretinal fluid and cystoid edema
Time Frame: one year
one year
Total number of treatments required
Time Frame: one year
one year
Timing of visual improvement after initiation of therapy
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bay Area Retina Associates

Collaborators

QLT Inc.

Investigators

  • Principal Investigator: Subhransu K Ray, M.D., Ph.D., Bay Area Retina Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDEX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age Related Macular Degeneration

Clinical Trials on ranibizumab, dexamethasone and verteporfin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe