Photodynamic Therapy Combined With Bevacizumab vs Bevaciz... | NCT00696592

Studies
Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-related Macular Degeneration

NCT00696592

Sponsor

University of Padova

Status

Withdrawn

Last Update Posted

Apr 24, 2025Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Neovascular Age-related Macular Degeneration

Interventions

Bevacizumab (Avastin), Verteporfin (Visudyne)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

new data from clinical trials

Expanded Access Info

Start Date

Jan 31, 2007Estimated

Primary Completion Date

Jan 31, 2008Actual

Completion Date

Jan 31, 2008Actual

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2025

Last Update Posted Date

Apr 24, 2025Actual

Name	Class
Department of Ophthalmology, Conegliano Hospital, Treviso, Italy	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This phase II study was designed to evaluate the safety, tolerability, and efficacy of bevacizumab treatment in conjunction with PDT at the low fluence rate compared with bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all types of choroidal neovascularization secondary to AMD.

Hypothesis: bevacizumab in combination with PDT (low and standard fluence rate) will i) delay time to retreatment, ii) reduce the average number of treatments required compared to bevacizumab alone and iii) at low PDT fluence rate will improve long-term safety profile.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
BVZ and PDT	Experimental		Drug: Bevacizumab (Avastin), Verteporfin (Visudyne)
BVZ only	Active Comparator		Drug: Bevacizumab (Avastin), Verteporfin (Visudyne)

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab (Avastin), Verteporfin (Visudyne)	Drug		BVZ and PDT BVZ only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Bevacizumab injections		One year
The mean change in best-corrected ETDRS visual acuity in the study eye		Months 6 and 12

Secondary Outcomes

Measure	Description	Time Frame
Mean change in total CNV area (Disc Areas)		Months 6 and 12
Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).		Months 6 and 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All lesion subtype of CNV secondary to age-related macular.
sub-foveal CNV.
patients who fail to respond to Photodynamic therapy.
patients who are not eligible for PDT (Greatest linear dimension of the lesion >/= 5400 um, CNV with hemorrhage >/= 50 % of the entire lesion, minimally classic or occult CNV with greatest linear dimension of the lesion >/= 4600 um.).
Patients affected by Pigment Epithelium Detachment with CNV.
Patients affected by Retinal Angiomatous Proliferation.
Willingness and ability to participate and provide written informed consent.

Exclusion Criteria:

Individuals with choroidal neovascularization from causes other than AMD (Myopia, Angioid Streaks).
Any intraocular surgery within 2 months in the study eye.
Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.
Any significant ocular disease that has compromised or could compromise vision in the study eye.
Prior stroke, myocardial infarction, or end-stage malignancy.
Active hepatitis or clinically significant liver disease, renal failure.
Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
Patients who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.
Patients who are a poor medical risk because of other systemic diseases or active uncontrolled infections.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins