/A

Phase 1

• Conditions: Diabetic macular edema; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]; MedDRA version: 14.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000004853

• Registration Number: EUCTR2004-004997-10-GB
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-04
• Study Completion: 2012-05-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 510

Inclusion Criteria

1. Male or female, at least 18 years of age
2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral hypoglycemic agents for the treatment of diabetes
- Diabetes defined as (ADA guidelines):
• Symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) plus plasma glucose concentration at any time of the day regardless of time since last meal = 200 mg/dl (11.1 mmol/l) or
• Eight-hour fasting plasma glucose = 126 mg/dl (7.0 mmol/l) or
• Two-hour postload (75 g) glucose = 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test
3. Diabetic macular edema in the study eye defined as clinically
observable macular edema involving the center of the macula (fovea)
associated with diabetic retinopathy, with any of the following
characteristics:
a) Prior medical therapy for diabetic macular edema
b) Prior macular laser(s) for diabetic macular edema with the most
recent laser at least 3 months prior to Baseline/ Qualification
where, in the opinion of the investigator, the patient will be able to
improve 15 or more letters in BCVA from baseline with the
resolution of the macular edema despite the presence of macular
laser scars
c) In the investigator’s opinion the patient would not benefit from
macular laser treatment
d) The patient refuses laser treatment
4. BCVA score between 34 letters (approximately 20/200 Snellen equivalent) and
68 letters (approximately 20/50 Snellen equivalent) in the study eye measured by the ETDRS method at qualification/baseline
5. Retinal thickness of = 300 µm by OCT in the 1mm central macular
subfield of the study eye at qualification/baseline as determined by the
investigator
6. Patients who have received intravitreal triamcinolone acetonide must
satisfy the following:
• The intended dose for each injection was 4 mg or less
• The most recent dose was at least 6 months prior to
qualification/baseline visit
• No treatment-related adverse event was seen that, in the
opinion of the investigator, has the potential to worsen or
reoccur with study treatment
7. Female patients of childbearing potential must have a negative urine pregnancy test at the randomization (day 0) visit
8. Written informed consent has been obtained
9. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained
10. Written Data Protection Consent (European sites only) has been obtained
11. Written documentation has been obtained, in accordance with state and country privacy requirements, where applicable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2

Exclusion Criteria

1. Uncontrolled systemic disease or current immunosuppressive diseases
(e.g. HIV+ or AIDS)
2. Initiation of medical therapy for diabetes or a change from oral
hypoglycemic agents to insulin therapy within 4 months prior to the
qualification/baseline visit
3. Blood HbA1c level greater than 10% at the qualification/baseline visit
4. Renal failure requiring hemodialysis or peritoneal dialysis within 6
months prior to the qualification/baseline visit
5. Adjusted glomerular filtration rate (GFR) less than 50 mL/min based on
the Modified Diet in Renal Disease (MDRD) formula adjusted for body
surface area, at the qualification/baseline visit
6. Any ocular condition in the study eye that in the opinion of the
investigator would prevent a 15-letter improvement in visual acuity
(e.g., severe macular ischemia, extensive macular laser scarring or
atrophy)
7. Presence of branch retinal vein occlusion, central retinal vein occlusion,
uveitis, pseudophakic cystoid macular edema or any other condition in
the study eye which could be contributing to macular edema
8. Presence of an epiretinal membrane or vitreo-retinal interface changes in
the study eye which, in the opinion of the investigator, is the primary
cause of macular edema, or is severe enough to prevent improvement in
visual acuity despite reduction in macular edema
9. History of IOP elevation in response to steroid treatment in either eye
that resulted in any of the following:
1) a = 10 mm Hg increase in IOP from baseline with an absolute IOP
=25 mm Hg
2) required therapy with 3 or more anti-glaucoma medications
10. History of glaucoma or optic nerve head change consistent with
glaucoma damage, and/or glaucomatous visual field loss in the study
eye. Patients with a history of previous angle-closure or similar
conditions that have been successfully treated with either a laser or
surgical peripheral iridotomy are allowed as long as the visual fields
and optic nerves have been stable for > 1 year prior to study entry and
the patient has been and can be safely dilated
11. Ocular hypertension in the study eye at qualification/baseline with any
of the following:
1) IOP > 23 mm Hg if taking no anti-glaucoma medications
2) IOP > 21 mm Hg if taking one anti-glaucoma medication
3) Use of 2 or more anti-glaucoma medications (combination products
should be considered 2 medications)
Note: Anti-glaucoma medications or lack thereof must be stable for at
least 4 weeks prior to qualification/baseline.
12. Aphakia or presence of anterior chamber intraocular lens in the study
eye
13. Active optic disc or retinal neovascularization in the study eye at
qualification/baseline
14. Active or history of choroidal neovascularization i

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified