Treatment of Refractory Diabetic Macular Edema With Infliximab

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00505947
• Date of registration: 23/07/2007
• Prospective Registration: No
• Primary sponsor: University of Athens
• Public title: Treatment of Refractory Diabetic Macular Edema With Infliximab
• Scientific title: Infliximab for Diabetic Macular Edema Refractory to Laser Photocoagulation: a Randomized, Double-Masked, Placebo-Controlled, Cross-Over, 32 Weeks Study
• Date of first enrolment: July 2007
• Target sample size: 12
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00505947
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Greece

Contacts

• Name: Petros Sfikakis, MD
• Affiliation: University of Athens

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have the capacity to understand and sign an informed consent form.

- Signed informed consent (must be obtained before any specific procedure is
performed).

- Presence of clinically significant macular edema, with visual acuity less than 0.4
corrected to EDRS scale, which is refractory to at least two sessions of laser
photocoagulation, defined as: A) Thickening of the retina at or within 500 µm of the
center of the macula. B) Hard exudates at or within 500 µm of the center of the
macula, if associated with thickening of the adjacent retina. C) A zone or zones
of retinal thickening 1 disc area or larger, any part of which is within 1 disc
diameter of the center of the macula.

- Male or female aged 18-80 years, inclusive.

- Type 1 or type 2 diabetes of at least 1 year duration. Type 1 diabetes is defined
clinically as a diagnosis made before the age of 36 years with a continuous need for
insulin within a year of diagnosis. Type 2 diabetes is defined clinically as a
diagnosis made at age of 36 or above without a need for continuous insulin therapy
within a year of diagnosis.

- Postmenopausal women (no menstrual cycle for a period of a minimum of 1 year) or
surgically sterilized and have a negative serum pregnancy test on entry in the study.
Men must agree to use adequate birth control during the study for 6 months after the
infusion of the study agent.

- Men and women of childbearing potential must use adequate birth control measures
(e.g. abstinence, oral contraceptives, intrauterine device, barrier method with
spermicide, implantable or injectable contraceptives or surgical sterilization) for
the duration of the study and should continue such precautions for 6 months after
receiving the last infusion.

- Stable diabetic therapy within the last 6 months, i.e. absence of major change in
glycemic control (e.g. 2% change in HbA1c) or change in daily number of insulin
injections.

- HbA1c 6.2-10%.

- The screening laboratory test must meet the following criteria: white blood cell
count >5x10/L; absolute neutrophil count >1x10/L; platelet count >50x10/L;
haemoglobin >100 g/L; serum creatinine <2 mg/dl; aspartate aminotransferase < 3 times
the upper normal limit; alanine aminotransferase <3 times the upper normal limit;
alkaline phosphatase < 2 times the upper normal limit, ?-GT< 2 times the upper normal
limit

- Patients are considered eligible according to the following tuberculosis (TB)
screening criteria: A)Have no history of latent or active TB prior to screening.
B)Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination. C)Have had no recent close contact with a person with active TB
or, if there has been such contact, will be referred to a physician specializing in
TB to undergo additional evaluation and, if warranted, receive appropriate treatment
for latent TB prior to or simultaneously with the first administration of study
agent. D) Within 1 month prior to the first administration of study agent, either
have a negative tuberculin skin test, as outlined in appendix B, or have a newly
identified positive tuberculin skin test during screening in which active TB has been
ruled out and for which appropriate treatment for latent TB has been initiated either
prior to or simultaneously with the first administration of study agent. E)Have a
chest radiograph (both posterior-anterior and lateral views), taken within 3 months
prior to the first administration of study agent and read by a qualified radiologist,
with no evidence of current active TB or old inactive TB.

Exclusion Criteria:

- Vitreoretinal traction.

- Retinal detachment.

- Proliferative diabetic retinopathy requiring immediate panretinal photocoagulation.

- Any previous eye surgery in the last 6 months before the beginning of the study
(intravitreal injections are not considered ocular surgery).

- Macular Edema of ischaemic type.

- Macular Edema caused by retinal conditions other than diabetes.

- Cataract or media opacities of a degree which precludes accurate retinal photographs
or OCT measurement.

- Hard exudates under the fovea.

- Uncontrolled hypertension (blood pressure above 180/110 mmHg).

- Angle closure glaucoma which precludes pharmacological dilatation of the pupil.

- Use in the previous 6 months of oral corticosteroids or in the previous month of
anti-inflammatory medication.

- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last
infusion) (this includes fathers who plan on fathering a child within 6 months after
their last infusion).

- Have had any previous treatment with monoclonal antibodies or antibody fragments.

- History of receiving human/murine recombinant products or a known allergy to murine
products. A known allergy to murine product is definitely an exclusion criterion.

- Documentation of seropositivity for human immunodeficiency virus (HIV).

- A positive test for hepatitis B surface antigen or hepatitis C virus (HCV).

- Have a history of alcohol or substance abuse within the preceding 6 months that, in
the opinion of the investigator, may increase the risks associated with study
participation or study agent administration, or may interfere with interpretation of
the results.

- Have a known history of serious infections (e.g. hepatitis, pneumonia, or
pyelonephritis) in the previous 3 months.

- Have or have had an opportunistic infection (e.g. herpes zoster, cytomegalovirus,
Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than
tuberculosis) within 6 months prior to screening.

- Positive PPD test.

- Have a chest radiograph at screening that shows evidence of malignancy, infection, or
any abnormalities suggestive of TB.

- Have a history of lymphoproliferative disease, including lymphoma or signs suggestive
of possible lymphoproliferative disease such as lymphadenopathy of unusual size or
location (e.g. nodes in the posterior triangle of the neck, infraclavicular,
epitrocheal, or periaortic area), or splenomegaly.

- Currently have a known malignancy or have a malignancy within the previous 5 years,
with the exception of basal or squamous cell carcinoma of the skin that has been
fully excised with no evidence of recurrence.

- Have current signs or symptoms of severe, progressive or uncontr


Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Retinopathy

Visual Acuity

Diabetic Macular Edema

Intervention(s)

Drug: infliximab

Drug: placebo

Primary Outcome(s)

improvement in best corrected visual acuity [Time Frame: 32 weeks]

Secondary Outcome(s)

anatomical improvement of diabetic macular edema and improvement in diabetic retinopathy [Time Frame: 32 weeks]

Secondary ID(s)

C0168X97

EU-0129

Source(s) of Monetary Support

Please refer to primary and secondary sponsors