NCT00370539

Brief Summary

To compare the efficacy and safety of photodynamic therapy (PDT) combined with intravitreal bevacizumab versus combination of photodynamic therapy , intravitreal bevacizumab and intravitreal triamcinolone for neovascular AMD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 14, 2006

Status Verified

November 1, 2006

First QC Date

August 30, 2006

Last Update Submit

November 13, 2006

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Photodynamic therapy,Bevacizumab,Triamcinolone,Age-related macular degeneration,Choroidal neovascular membrane

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

Secondary Outcomes (4)

  • Central macular thickness

  • Leakage in fluorescein angiography

  • Intraocular pressure

  • Anterior chamber reaction

Interventions

verteporfin, bevacizumab, triamcinolone acetonideDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases of active neovascular AMD with visual acuity of 20/400- 20/40

You may not qualify if:

  • History of glaucoma or ocular hypertension
  • Disciform scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh, MD

Tehran, Tehran Province, 16666, Iran

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

VerteporfinBevacizumabTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, Fluorinated

Study Officials

  • Hamid Ahmadieh, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid Ahmadieh, MD

CONTACT

+98 21 22585952hahmadieh@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

September 1, 2006

Study Completion

November 1, 2006

Last Updated

November 14, 2006

Record last verified: 2006-11

Locations

IR(1)