A Phase II Randomized Study to Compare Anti-VEGF Agents in the Treatment of Diabetic Macular Edema (CADME) - A Study to Compare Anti-VEGF Agents in the Treatment of DME (CADME)

Phase 1

• Conditions: Diabetic Macular Edema (DME); MedDRA version: 15.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-005486-13-GB
• Lead Sponsor: The National Eye Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-06
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(1) Participant is 18 years of age or older. (2) Participant has a diagnosis of diabetic 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 anti-hyperglycemia agents for the treatment of diabetes; Documented diabetes by ADA and/or WHO criteria. (3) Participant must understand and sign the protocol’s informed consent document. (4) Female participants of childbearing potential (see Appendix 1 for definition) must not be pregnant or breast-feeding and must have a negative pregnancy test at screening and must agree to pregnancy testing throughout the study. (5) Female participants of childbearing potential (see Appendix 1) and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for four weeks after their last injection. Acceptable methods of contraception include: Hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring); Intrauterine device; Barrier methods (i.e., diaphragm, condom) with spermicide; or Tubal ligation. (6) Participant has at least one eye that meets all of the following criteria: eye has a BCVA ETDRS score between 20/32 and 20/400; eye has definite retinal thickening or cystic changes due to DME based on clinical exam involving the center of the macula that is not refractory to further therapy as based on the investigator’s clinical judgment; eye has retinal thickness in the central subfield on baseline OCT measurement = 330 microns, as measured by Cirrus™ OCT; eye has clear ocular media and adequate pupillary dilation sufficient for adequate fundus photographs; eye does not have macular edema considered to be due to a cause other than diabetes (an eye is not eligible if: the macular edema is considered to be related to cataract extraction, or clinical examination and/or OCT suggest that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema); eye does not have an ocular condition present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition); eye does not have an ocular condition present (other than DR) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.); eye does not have a history of panretinal scatter photocoagulation (PRP) within three months prior to enrollment; eye does not have a history of prior pars plana vitrectomy prior to enrollment; eye does not have a history of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within three months prior to enrollment; eye does not have a history of Yttrium-Aluminum-Garnet (YAG) capsulotomy performed within two months prior to enrollment; eye has not had laser photocoagulation treatment, or received intravitreal or periocular steroids within three months prior to enrollment; eye does not have a history of int

Exclusion Criteria

(1) Participant is in another investigational study and actively receiving investigational product for DME. (2) Participant has a known hypersensitivity to sodium fluorescein dye. (3) Participant has 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). (4) Participant has a history of chronic renal failure requiring dialysis or kidney transplant. (5)Participant has a history of liver failure. (6) Participant has a known hypersensitivity to bevacizumab, ranibizumab or any of their components. (7) Participant has a blood pressure of > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, a patient can become eligible. (8) Participant has a history of treatment with oral steroids ( = 10 mg of prednisone daily or equivalent) within three months prior to enrollment. Non-ocular depot and inhaled steroid treatments will not exclude a participant. (9) Participant has a history of treatment with systemic anti-VEGF agents within four weeks prior to enrollment.

Study & Design

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