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| Sponsor: | Bay Area Retina Associates |
|---|---|
| Collaborator: |
QLT Inc |
| Information provided by: | Bay Area Retina Associates |
| ClinicalTrials.gov Identifier: | NCT00390208 |
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 II |
| 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. |
| 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
|
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 |
Inclusion Criteria:
(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
Lesion must be less than 12 disc areas
Lesion size must be less than 12 disc areas.
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Subhransu K Ray, M.D., Ph.D. | Bay Area Retina Associates |
More Information
| 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 |
|
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 |
|
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 |