Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia

NCT01968486 | Completed Phase 1 DMC

• 1 other identifier: fidelio
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate the efficacy of ranibizumab in combination with reduced-fluence verteporfin photodynamic therapy (RF-PDT) in patients with subfoveal choroidal neovascularization secondary to pathologic myopia (PM).

Conditions

Myopia, Degenerative

Outcome Measures

Primary Outcomes (1)

• Mean change in best-corrected visual acuity (BCVA) from baseline

  24 weeks

Study Arms (3)

PDT Standard Fluence, ranibizumab

EXPERIMENTAL

verteporfin (6 mg/m2) SF (wavelength, 689 nm; dose, 50 J/cm2; light intensity, 600 milliwatt(mW)/cm2 for 83 s) plus 0.5 mg intravitreal ranibizumab

Drug: PDT standard fluence, ranibizumab

PDT Reduced Fluence, ranibizumab

EXPERIMENTAL

verteporfin (6 mg/m2) RF ( wavelength, 689 nm; dose, 25 J/cm2 ; light intensity, 300 mW/cm2 for 83 s) plus 0.5 mg intravitreal ranibizumab

Drug: PDT reduced fluence, ranibizumab

ranibizumab

EXPERIMENTAL

0.5 mg (10 mg/ml) intravitreal ranibizumab.

Drug: ranibizumab

Interventions

PDT standard fluence, ranibizumab DRUG

In the verteporfin PDT combination therapy arm patients were treated on day one with 0.5 mg (10 mg/ml) IVR injection and after seven days with PDT standard fluence (wavelength, 689 nm; dose, 50 J/cm2; light intensity, 600 mW/cm2 for 83 s). Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid \> 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.

Also known as: Photodynamic therapy

PDT Standard Fluence, ranibizumab

PDT reduced fluence, ranibizumab DRUG

In the verteporfin PDT combination therapy arm patients were treated on day one with 0.5 mg (10 mg/ml) IVR injection and after seven days with PDT reduced fluence ( wavelength, 689 nm; dose, 25 J/cm2 ; light intensity, 300 mW/cm2 for 83 s).Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid \> 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.

Also known as: Photodynamic therapy

PDT Reduced Fluence, ranibizumab

ranibizumab DRUG

In the ranibizumab monotherapy arm patients were treated with a loading phase of three consecutive 0.5 mg (10 mg/ml) IVR injections every six weeks. Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid \> 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.

Also known as: Lucentis

ranibizumab

Eligibility Criteria

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

You may qualify if:

• pathologic myopia, defined as spherical equivalent greater than 6 D and axial length more than 26 mm (Carl Zeiss IOLMaster V 4.07; Carl Zeiss Meditec, Dublin, California, USA);
• posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
• fluorescein angiography (FA) detection of the subfoveal or juxtafoveal CNV (CNV was classified as juxta-foveal if the lesion was closer than 200 mm but not under the geometric center of the foveal avascular zone);
• clear ocular media;
• duration of symptoms no longer than 4 weeks before enrollment.

You may not qualify if:

• prior treatment for CNV including previous intravitreal drugs injection or PDT-V;
• presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion;
• history of recent myocardial infarction or other thromboembolic events;
• ongoing uncontrolled hypertension or glaucoma;
• refractive media opacities;
• eye surgery.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

MeSH Terms

Conditions

Myopia, Degenerative

Interventions

Ranibizumab; Photochemotherapy

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Flavia Chiosi, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: October 24, 2013
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 28, 2013

Record last verified: 2013-10