None listed
Conditions
Interventions
PF-04523655 0.4 mg intravitreal injection each month during six months
Group 1 Type of group
Necessity of laser treatment is assessed every three months.
Group name:Group 4 Type of group
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • History of diabetes meillitus (Type 1 or Type 2). • HbA1c in serum> 5.5% and 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.
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measured by the ETDRS protocol for visual acuity. Measure:Average change with respect to the baseline (Day 0) in Month 24 in the best corrected visual acuity score (BCVA) Timepoints:Month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Identified by ophthalmological examination and / or spontaneously informed. Measure:Incidence and severity of ocular adverse events Timepoints:Month 24 ; Outcome name:Changes in vital signs, clinical laboratory abnormalities and / or spontaneously reported. Measure:Incidence and severity of systemic adverse events Timepoints:Month 24 ; Outcome name:Measured by the number of letters read correctly according to the ETDRS protocol for visual acuity. Measure:Percentage of participants who won> 15 letters in the best corrected visual acuity score (BCVA) compared to baseline for study visit scheduled until Month 36 Timepoints:Month 36 ; Outcome name:Measured by the number of letters read correctly according to the ETDRS protocol for visual acuity. Measure:Percentage of participants who won if O letters in the best corrected visual acuity score (BCVA) with respect to baseline for study visit scheduled until Month 36 Timepoints:Month 36 ; Outcome name:Measured by the number of letters read correctly according to the ETDRS protocol for visual acuity. Measure:Percentage of participants who lost <15 letters in the BCVA score with respect to the baseline due to a scheduled study visit until Month 36 Timepoints:Month 36 ; Outcome name:Measured by the number of letters read correctly according to the ETDRS protocol for visual acuity. Measure:Average changes in the BCVA score with respect to the baseline per scheduled study visit until Month 36 Timepoints:Month 36 ; Outcome name:Evaluated by OCT. Measure:Average changes in the thickness of the central subfield of the retina with respect to the baseline per scheduled study visit until Month 36 Timepoints:Month 36 ; Outcome name:Evaluated by OCT. Measure:Mean changes in macular volume with respect to baseline per scheduled study visit until Month 36 Timepoints:Month 36 ; Outcome name:Evaluated by FA. | — |
Countries
Brazil, Denmark, Germany, India, Israel, Italy, Peru, United Kindgdom, United States
Contacts
Public ContactLuciana Obreros
PFIZER S.A.
Outcome results
None listed