Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

NCT ID: NCT00473642

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-04-30

Brief Summary

In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.

The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

Conditions

Age-Related Maculopathy; Choroidal Neovascularization

Keywords

Ranibizumab; Lucentis; Verteporfin; Visudyne; Photodynamic therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Standard Fluence Photodynamic Therapy combined with ranibizumab

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin

Intervention Type: DRUG

Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

2

Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Verteporfin

Intervention Type: DRUG

Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

3

Ranibizumab monotherapy

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Interventions

Ranibizumab

intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Intervention Type: DRUG

Verteporfin

Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

Intervention Type: DRUG

Verteporfin

Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Intervention Type: DRUG

Other Intervention Names

Lucentis; Visudyne; Visudyne

Eligibility Criteria

Inclusion Criteria

1. Male or Female Patients > 50 years of age.

2. Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.

3. Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.

4. If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.

5. Patients must be able and willing to provide written informed consent.

Exclusion Criteria

1. Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.

2. Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.

3. Choroidal neovascular membrane greater than 9 disc diameters in size.

4. Previous posterior vitrectomy in the study eye.

5. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.

6. Pregnant women or premenopausal women not using adequate contraception.

7. History of allergy to fluorescein, Visudyne, Lucentis.

8. Inability to comply with study or follow up procedures.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott J Westhouse, DO

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Medical Center

Raymond Townsend, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Medical Center

John Saurino, DO

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Medical Center

Locations

Eagle Mountain Vision

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

2007002

Identifier Type: -

Identifier Source: org_study_id