Pilot Study Reduced Fluence PDT /Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-related Macular Degeneration (AMD)

NCT00726973 | Withdrawn

• 1 other identifier: 2006-085
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of this study is to determine if combination reduced fluence photodynamic therapy and Ranibizumab has: Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number of PDT treatments. The study will also collect information on the safety of combination therapy and single therapy.

Conditions

Macular Edema

Keywords

Macular edema

Outcome Measures

Primary Outcomes (1)

• Primary efficacy will be proportion of subjects with best corrected visual acuity improvement of 15 or more letters from baseline and wil visual acuity stabilization, less than 15 letter loss from baseline at 13 months

  at conclusion of subject enrollment

Secondary Outcomes (1)

• Mean change in ETDRS from baseline, number of Ranibizumab treatments w/reduced fluence PDT, proportion of patients with 6 lines of vision loss

  at conclusion of subject enrollment

Study Arms (2)

1

EXPERIMENTAL

Reduced fluence (3300mW/cm2-50% standard fluence) PDT + ranibizumab

Drug: Ranibizumab

2

ACTIVE COMPARATOR

Ranibizumab monotherapy

Drug: Ranibizumab monotherapy

Interventions

Ranibizumab DRUG

Ranibizumab, and reduced fluence PDT or sham PDT and Ranibizumab. For 2 months injected intravitreal Ranibizumab will be given. At month 3 subjects will receive combination reduced fluence PDT and intravitreal Ranibizumab. If they develop recurrence of subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness \>100 microns compared to best thickness measure of OCT, subjects will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab every 3 months thereafter.

Also known as: Lucentis

1

Ranibizumab monotherapy DRUG

3 monthly intravitreal injections of Ranibizumab monotherapy. After month 2 they are eligible for retreatment with Ranibizumab if retreatment criteria are met (same as arm 1) At intervals of no less than 3 months from the previous sham PDT they will receive sham PDT if retreatment criteria are met.

Also known as: lucentis

2

Eligibility Criteria

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

You may qualify if:

• Male / Female \> 50 years of age
• FA diagnosis of CNV lesions as described above
• Have a best corrected visual acuity letter score in the study eye between 72-24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters
• Central retinal (including lesion) thickness greater than or equal to 250 microns as measured by OCT
• Subretinal hemorrhage making up less than 50% of total lesion size and sparing the fovea
• Sufficiently clear ocular media including the lens to allow photography of the retina
• Written informed consent has been obtained.

You may not qualify if:

• Dense subfoveal hemorrhage (\>50% of the lesion)
• Tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV
• Geographic atrophy involving the foveal center
• Subretinal fibrotic scar in the study eye greater than 25% of the lesion
• Presence of any condition in study eye other than AMD known to be associated with CNV
• History diabetic retinopathy or diabetic macular edema
• Previous pars plana vitrectomy
• Previous photodynamic therapy in the study eye
• Previous photodynamic therapy in the fellow eye with resultant choroidal hypoperfusion
• Previous intravitreal anti-VEGF or steroid injection in the study eye
• Previous thermal subfoveal laser treatment in study eye
• Anticipated need for ocular surgery in the study eye during the 13 month study period
• Known allergy or sensitivity to the study medication(s) its components, diagnostic agents used during the study (Fluorescein, dilation drops) or other agents required for the study procedures (ie: povidone iodine)
• Porphyria or other porphyrin sensitivity

Sponsors & Collaborators

• Lahey Clinic: lead

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jeffrey L Marx, M.D.

  Lahey Clinic Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: December 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 10, 2012

Record last verified: 2012-05