A Phase II Prospective, Randomized, Multi-Center, Diabetic Macular Edema Dose Ranging, Comparator Study Evaluating The Efficacy And Safety Of PF-04523655 Versus Laser Therapy (DEGAS)
- Conditions
- E113-H36-E103 Insulin-dependent diabetes mellitus, with ophthalmic complications-E113 Non-insulin-dependent diabetes mellitus, with ophthalmic complicationsInsulin-dependent diabetes mellitus, with ophthalmic complicationsE103Non-insulin-dependent diabetes mellitus, with ophthalmic complicationsH36
- Registration Number
- PER-153-08
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• History of diabetes meillitus (Type 1 or Type 2).
• HbA1c in serum> 5.5% and <12% in the selection visit.
• Participants with diabetic macular edema affecting the fovea, consisting of a retinal thickness at the OCT measuring 275 pm or more in the central subfield at the selection visit.
• Decreased visual acuity as a result of the thickening of the retina that affects the center of the fovea and the best corrected visual acuity, using the visual acuity protocol of the Study of Early Treatment of Diabetic Retinopathy (ETDRS) ) of 20/40 or worse (score for letters of <73) and up to 20/320 or better (score for letters of> 24) in the study eye on the selection visit.
• Visual acuity score in the contralateral eye of 20/400 or better (score for letters of> 19) in the selection visit.
• Treatment for diabetic macular edema with laser photocoagulation can be suspended for at least 90 days after the participant has enrolled in the study.
• Ocular means and adequate dilation of the pupil to allow a good quality OCT and a stereoscopic photograph of the fundus.
• Evidence of a personally signed and dated informed consent indicating that the participant (or a legally acceptable representative) has been informed of all aspects related to the study.
• Participants who are willing to comply with scheduled visits, treatment plan, laboratory tests and other study procedures such as telephone access from the center! telephone for administration of NEI-VFQ- 25.
• Men and women over 18 years of age. Women of non-fertile age (undergoing hysterectomies or believed to be postmenopausal as evidenced by a 3-year history of amenorrhea) or of childbearing age are eligible, provided they have a negative urine pregnancy test at the Selection visit and basal. Women of childbearing age should be willing to use (at least two forms of) appropriate contraceptive methods as described below during the treatment period and for 3 months after the last dose of the study drug. Men with partners of childbearing age must agree to use (at least one form of) appropriate contraception as described below during the treatment period and for 3 months after the last dose of the study drug or be surgically sterile.
• Parenteral photocoagulation or macular photocoagulation performed in the study eye within 3 months of the selection visit.
• Participants receiving concomitant intravitreal therapy with anti-VEGF in the non-study eye. The use of intravitreal asteroids in the non-study eye is allowed.
• Any concurrent intraocular condition in the study eye or previous surgery (for example, cataract, vitrectomy) that, in the opinion of the investigator, may (a) require medical or surgical intervention during the 36-month study period to prevent or treat ia visual loss that could result from such condition, or (b) that if progress were left untreated, it could possibly contribute to a loss of at least 2 ETDRS lines of the best corrected visual acuity over a period of 36 months (c) it can affect macular edema or reduce visual acuity during the course of the study for example, uveitis / inflammatory eye disease, venous occlusions, Irvine-Gass syndrome.
• Cataract surgery in the study eye within 2 months prior to enrollment in the study.
• High-risk diabetic proiiferative retinopathy (PDR) in the study eye. Inactive fibrosed neovascularization is permitted after laser therapy (PRP) and PRP which is not high risk if no evidence of vitreous hemorrhage is observed.
• Infectious conjunctivitis, keratitis, scleritis or current endophthalmia in any of the eyes.
• Aphakia or absence of the posterior capsule in the study eye. Previous capsulotomy with Garnet Aluminum Itrium (YAG) performed 2 months or more before admission to the study associated with the posterior intraocular lens implant is allowed.
• Structural damage to the center of the macula in the study eye that is likely to prevent an improvement in visual acuity after the disappearance of macular edema, including among others a persistent DME that affects the fovea center of more than 2 years duration, atrophy of the retinal pigment epithelium, sub-retinal fibrosis, macular ischemia defined by an enlargement of the foveal avascular area (FAZ> 1000 pm in fluorescein fundus angiography), laser scar (ces), plaque Organized hard exudative, vitreomacular traction, epiretinal membrane evident on ophthalmic examination or by OCT.
• Uncontrolled glaucoma (defined as treatment for ocular pressure with anti-glaucoma drugs) with lOP> 30 mm Hg and / or advanced scarification of the optic disc with glaucomatous visual field loss.
• Participants who have a history of any severe acute or chronic medical or psychiatric condition or a laboratory abnormality that could increase the risk associated with participating in the study or that could interfere with the interpretation of the study results and that, at the discretion of the researcher, could return the inappropriate participant to enter this study;
• Participants with blood pressure> 180/110 should be excluded at the selection visit. Participants with blood pressure equal to or less than 180/110 with antihypertensive drugs can enroll in the study.
• Participants who show a clinical and significantly abnormal ECG, which suggests ischemic heart disease, clinically significant cardiac arrhythmias, atrioventricular block, congestive heart failure determined by a physician in the evaluation. If a clinically significant abnormality is shown in the selection, the ECG in the base must be reassessed! to determine eligibility.
• Participation in other research studies of either systemic or topical drugs within 2 months prio
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Measured by the ETDRS protocol for visual acuity.<br>Measure:Average change with respect to the baseline (Day 0) in Month 24 in the best corrected visual acuity score (BCVA)<br>Timepoints:Month 24<br>
- Secondary Outcome Measures
Name Time Method