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

Sponsor

Bay Area Retina Associates (Other)

Overall Status

Completed

CT.gov ID

NCT00390208

Collaborator

QLT Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

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. [one year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bay Area Retina Associates	Castro Valley	California	United States	94546
2	Bay Area Retina Associates	Walnut Creek	California	United States	94598
3	Georgia Retina	Riverdale	Georgia	United States	30274
4	Retina Vitreous Associates	Toledo	Ohio	United States	43608