Age Related Macular DegenerationPhase 2NCT00729846

Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

A Phase 2 study testing Bevacizumab, verteporfin photodynamic therapy reduced fluence and verteporfin photodynamic therapy standardfluence in people with Age Related Macular Degeneration and Choroidal Neovascularization, run by California Retina Consultants at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Age Related Macular Degeneration, Choroidal Neovascularization, Macular Edema
What is being tested?: Bevacizumab, verteporfin photodynamic therapy reduced fluence and verteporfin photodynamic therapy standardfluence
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 2 sitesUnited States
Study dates: May 2006to Jul 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients are men or women of age 50 or older.
Patients have not received previous treatment for subfoveal choroidal neovascularization (CNV).
Patients must have evidence of active or recurrent subfoveal CNV as confirmed by fluorescein angiography.
The total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns.
Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. Only one eye will assessed in the study.
The CNV lesion must be primarily CNV (i.e. CNV equal to or greater than 50% of the lesion.
The CNV is associated with only macular degeneration.
Patient defers other approved treatments of subfoveal CNV associated with AMD.

Who cannot join

Prior treatment for subfoveal choroidal neovascularization (CNV).
Prior treatment for juxtafoveal or extrafoveal CNV involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate.
History of vitrectomy or submacular surgery in the study eye.
Subretinal fibrosis accounting for more than 50% of the lesion.
Non-CNV lesion components account for more than 50% of the total lesion components.
CNV due to causes other than AMD.

Show all 16Show fewer

Retinal pigmented epithelial tear involving the center of the macula.
Geographic atrophy involving the central macula.
Any concurrent intraocular condition in the study eye that in the opinion of the investigator could require surgical or medical intervention during the course of the study (i.e. cataract).
Active intraocular inflammation.
Vitreous hemorrhage in the eye.
History of spherical equivalent in the study eye greater than negative 8 diopters.
Intraocular surgery within 2 months of study enrollment.
Uncontrolled glaucoma in the study eye. Defined as intraocular pressure greater than 30mmHg despite treatment with anti-glaucoma medication.
History of other disease, such as recent myocardial infarction, recent cerebral vascular accident, or uncontrolled hypertension that in the opinion of the investigator might render the subject at high risk for complication.
Inability to comply with study or follow-up procedures.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

California Retina Consultants
Bakersfield, California, 93309
California Retina Consultants
Santa Barbara, California, 93103

Other trials in United States

About this study

Official title: Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration

Conditions: Age Related Macular Degeneration, Choroidal Neovascularization, Macular Edema
Being tested: Bevacizumab, verteporfin photodynamic therapy reduced fluence, verteporfin photodynamic therapy standardfluence
Keywords: choroidal neovascularization, macular degeneration, macular edema, intravitreal bevacizumab, vegf, verteporfin PDT
Medical subject headings: Macular Degeneration, Choroidal Neovascularization, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BevacizumabDrug
Also called Avastin, visudyne
Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
verteporfin photodynamic therapy reduced fluenceDevice
Also called PDT
Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].
verteporfin photodynamic therapy standardfluenceDevice
Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].

Study groups in NCT00729846
Study group	Role	What they receive
A	Experimental	Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. Receives: Drug: Bevacizumab; Device: verteporfin photodynamic therapy reduced fluence
B	Experimental	Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. Receives: Drug: Bevacizumab; Device: verteporfin photodynamic therapy standardfluence

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Jul 2009

First posted8 Aug 2008 (estimated)
Study startMay 2006
Primary completionAug 2008
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00729846
Sponsor's protocol ID: BPDT2006
Status last verified: Mar 2016
First submitted: 5 Aug 2008
Last updated: 20 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
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Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
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RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT00729846
Acronym / sponsor ID: BPDT2006
Conditions: Age Related Macular Degeneration, Choroidal Neovascularization, Macular Edema
Keywords: choroidal neovascularization, macular degeneration, macular edema, intravitreal bevacizumab, vegf, verteporfin PDT
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: California Retina ConsultantsUniversity, hospital or other
Collaborators: Novartis
Study start: May 2006
Primary completion: Aug 2008 (actual)
Study completion: Jul 2009 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 20 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Bevacizumab, Device: verteporfin photodynamic therapy reduced fluencePatients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
B	Experimental	Drug: Bevacizumab, Device: verteporfin photodynamic therapy standardfluencePatients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients are men or women of age 50 or older.
Patients have not received previous treatment for subfoveal choroidal neovascularization (CNV).
Patients must have evidence of active or recurrent subfoveal CNV as confirmed by fluorescein angiography.
The total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns.
Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. Only one eye will assessed in the study.

Key exclusion criteria (16 listed)

Prior treatment for subfoveal choroidal neovascularization (CNV).
Prior treatment for juxtafoveal or extrafoveal CNV involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate.
History of vitrectomy or submacular surgery in the study eye.
Subretinal fibrosis accounting for more than 50% of the lesion.
Non-CNV lesion components account for more than 50% of the total lesion components.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BevacizumabAlso: Avastin, visudynePatients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.	Drug	A, B
verteporfin photodynamic therapy reduced fluenceAlso: PDTPatients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].	Device	A
verteporfin photodynamic therapy standardfluencePatients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].	Device	B

Primary outcome

Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
Time frame: 1 Year

Results and safety

Results posted to the registry on 20 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reduced Fluence	11	11
Standard Fluence	11	11

Primary outcome: Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.

Time frame: 1 Year. Number. Unit: percent of participants

Measure	Reduced Fluence n = 11	Standard Fluence n = 11
Value	80	90

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reduced Fluence	0 of 11 (0%)	0 of 11 (0%)	Not reported
Standard Fluence	0 of 11 (0%)	0 of 11 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
California Retina Consultants WebsiteLink provided by the sponsor.

Related trials for Age Related Macular Degeneration

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
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RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dante J Pieramici, MD principal investigator

California Retina Consultants

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. (time frame: 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00729846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.