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

NCT00473642 | Completed Phase 4 Results

• 1 other identifier: 2007002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months

  Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.

  12 months

• Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol

  Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.

  12 months

Secondary Outcomes (4)

• Time to First Retreatment After Loading Doses

  12 months

• Average Number of PDT Retreatments Over 12 Months

  12 months

• Central Macular Thickness Reduction on OCT

  12 months

• Average Number of Ranibizumab Retreatments Over 12 Months

  12 months

Study Arms (3)

1

EXPERIMENTAL

Standard Fluence Photodynamic Therapy combined with ranibizumab

Drug: Ranibizumab; Drug: Verteporfin

2

EXPERIMENTAL

Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab

Drug: Ranibizumab; Drug: Verteporfin

3

ACTIVE COMPARATOR

Ranibizumab monotherapy

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Also known as: Lucentis

1; 2; 3

Verteporfin DRUG

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

Also known as: Visudyne

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female Patients \> 50 years of age.
• Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
• 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.
• 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.
• Patients must be able and willing to provide written informed consent.

You may not qualify if:

• 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.
• Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.
• Choroidal neovascular membrane greater than 9 disc diameters in size.
• Previous posterior vitrectomy in the study eye.
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.
• Pregnant women or premenopausal women not using adequate contraception.
• History of allergy to fluorescein, Visudyne, Lucentis.
• Inability to comply with study or follow up procedures.

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead
• Novartis: collaborator

Study Sites (1)

Eagle Mountain Vision

Tulsa, Oklahoma, 74132, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Ranibizumab; Verteporfin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

This study was limited by a small number of subjects. Additionally, several subjects did not meet the 12 month study endpoint. These subjects were included in the final analysis if their last visit was within 2 months of the final endpoint.

Results Point of Contact

• Title: Scott Westhouse, DO
• Organization: Retina Specialists of Michigan

s.westhouse@gmail.com

616-954-2020

Study Officials

• Scott J Westhouse, DO

  Oklahoma State University Medical Center

  PRINCIPAL INVESTIGATOR

• Raymond Townsend, MD

  Oklahoma State University Medical Center

  PRINCIPAL INVESTIGATOR

• John Saurino, DO

  Oklahoma State University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: April 1, 2010
• Last Updated: November 6, 2020
• Results First Posted: November 8, 2012

Record last verified: 2020-11

Locations

US (1)