NCT01920984

Brief Summary

To determine the vitreous levels of fractalkine, cysteine-rich 61 (Cyr61), and VEGF in patients with PDR. Verifying that it is greater to that found in non-diabetic patients with different non-angiogenetic diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
Last Updated

August 13, 2013

Status Verified

January 1, 2004

Enrollment Period

1.9 years

First QC Date

August 8, 2013

Last Update Submit

August 12, 2013

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Vitreous levels of Fractalkine, Cyr61, and VEGF of patients with proliferative diabetic retinopathy

    7 days

Study Arms (2)

pretreatment of bevacizumab

EXPERIMENTAL

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy due to diabetic retinopathy.

Drug: intravitreal injection of 1.25 mg of bevacizumab

No pretreatment of bevacizumab

NO INTERVENTION

Patients will not receive bevacizumab pretreatment before vitreous surgery.

Interventions

intravitreal injection of 1.25 mg of bevacizumabDRUG

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy

Also known as: Bevacizumab(Avastin, Genentech, Inc., South San Francisco)
pretreatment of bevacizumab

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Patients with type 1 or type 2 diabetes mellitus
  • Not eligible for any currently approved treatments or experimental protocols
  • Patients with PDR who receiving vitreoretinal surgery.

You may not qualify if:

  • A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure
  • Panretinal laser photocoagulation in the study eye
  • Previous treatment with intravitreal or sub-Tenon triamcinolone
  • History of submacular surgery or other surgical intervention for diabetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • Watanabe D, Suzuma K, Matsui S, Kurimoto M, Kiryu J, Kita M, Suzuma I, Ohashi H, Ojima T, Murakami T, Kobayashi T, Masuda S, Nagao M, Yoshimura N, Takagi H. Erythropoietin as a retinal angiogenic factor in proliferative diabetic retinopathy. N Engl J Med. 2005 Aug 25;353(8):782-92. doi: 10.1056/NEJMoa041773.

    PMID: 16120858BACKGROUND

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Chung-Hao Yang, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 13, 2013

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 13, 2013

Record last verified: 2004-01

Locations

TW(1)