NCT00959725

Brief Summary

The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

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

Study Start

First participant enrolled

August 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

August 14, 2009

Last Update Submit

August 14, 2009

Conditions

Diabetic Macular Edema

Keywords

InfliximabDiabetesMacular Edema

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

    Three months

Secondary Outcomes (1)

  • Macular thickness

    One, two, and three months

Study Arms (1)

Intravitreal infliximab.

EXPERIMENTAL
Drug: Infliximab (intravitreal, 2.0mg/0.05ml)

Interventions

Infliximab (intravitreal, 2.0mg/0.05ml)DRUG

One injection of intravitreal infliximab (2.0mg/0.05ml).

Also known as: Remicade™
Intravitreal infliximab.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must be 18 years of age or older.
  • Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation.
  • Participant must have a negative PPD skin test.
  • Participant must understand and sign the protocol's informed consent document.
  • Participants must have DME as defined by all of the following criteria:
  • Presence of diabetes (type I or type II)
  • Macular edema defined as a central macular thickness of ≥ 250μm on OCT.
  • Participant must have visual acuity between 20/40 and hand motions in the study eye.
  • Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
  • Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.

You may not qualify if:

  • Participant is in another investigational study and actively receiving study therapy.
  • Participant has proliferative diabetic retinopathy.
  • Participant is unable to comply with study procedures or follow-up visits.
  • Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
  • Participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (e.g., uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
  • Participant is expected to need ocular surgery or panretinal photocoagulation in the study eye during the course of the study.
  • Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
  • Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
  • Participant has had a pars plana vitrectomy in the study eye.
  • Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
  • Participant with a history of ocular herpes simplex virus infection in the study eye.
  • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

Related Publications (4)

  • Theodossiadis PG, Liarakos VS, Sfikakis PP, Vergados IA, Theodossiadis GP. Intravitreal administration of the anti-tumor necrosis factor agent infliximab for neovascular age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):825-30, 830.e1. doi: 10.1016/j.ajo.2008.12.004. Epub 2009 Feb 10.

    PMID: 19211094BACKGROUND

  • Theodossiadis PG, Liarakos VS, Sfikakis PP, Charonis A, Agrogiannis G, Kavantzas N, Vergados IA. Intravitreal administration of the anti-TNF monoclonal antibody infliximab in the rabbit. Graefes Arch Clin Exp Ophthalmol. 2009 Feb;247(2):273-81. doi: 10.1007/s00417-008-0967-4. Epub 2008 Nov 4.

    PMID: 18982345BACKGROUND

  • Giansanti F, Ramazzotti M, Vannozzi L, Rapizzi E, Fiore T, Iaccheri B, Degl' Innocenti D, Moncini D, Menchini U. A pilot study on ocular safety of intravitreal infliximab in a rabbit model. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1151-6. doi: 10.1167/iovs.07-0932.

    PMID: 18326743BACKGROUND

  • Olson JL, Courtney RJ, Mandava N. Intravitreal infliximab and choroidal neovascularization in an animal model. Arch Ophthalmol. 2007 Sep;125(9):1221-4. doi: 10.1001/archopht.125.9.1221.

    PMID: 17846362BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusMacular Edema

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Farzin Forooghian, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roje-Oktay Kacmaz, MD

CONTACT

212-824-7645roje-oktay.kacmaz@mssm.edu

Farzin Forooghian, MD

CONTACT

212-241-0939farzin.forooghian@mssm.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations

US(1)