Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE)

Completed · Phase 1/Phase 2

Conditions studied: Diabetic Macular Edema

In brief

This study is a Phase I/II, multicenter, randomized, study of the efficacy and safety of ranibizumab injection monotherapy verses a duel therapy of 0.3mg ranibizumab combined with ultra wide, 200° field angiography guided pan retinal photocoagulation in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2).

Key facts

Study ID

NCT01552408

Run by

David M. Brown, M.D.

People needed

29

Starts

2012-03-01

Expected to finish

2017-05-18

Last updated by the study team

2018-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Age ≥ 18 years
• Diabetes Mellitus (Type 1 or 2). The following will be considered as sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes
• Current regular use of oral antihyperglycemic agents for the treatment of diabetes
• Documented diabetes according to the American Diabetes Association and/or World Health Organization criteria.
• BCVA score in the study eye of 20/32 to 20/320 approximate snellen equivalent using the ETDRS protocol at an initial testing distance of 4 meters, confirmed by the investigator.
• High Definition OCT (Spectralis) central retinal thickness measurement of ≥ 300 µm
• Decrease in visual acuity is determined to be primarily the result of DME and not to other cause.
• Ability and willingness to return for all scheduled visits and assessments.
• Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from this study:
• General Exclusion Criteria
• Pregnancy (positive pregnancy test) or lactation
• Sexually active women of childbearing potential* who are unwilling to practice adequate contraception or abstinence during the study. (*Although no birth control method is 100% effective, the following are considered adequate means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, intrauterine devices, or contraceptive hormone implants or patches. A subject's primary care physician, obstetrician, or gynecologist should be consulted regarding an appropriate form of birth control)
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial] Ocular Exclusion Criteria
• Prior Ocular Treatment:
• History of vitrectomy surgery in the study eye
• Any pan-retinal photocoagulation in the study eye
• Prior treatment with intraocular or subconjunctival steroids in the study eye 4 months prior to screen
• Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 2 months of Day 0 visit
• Systemic corticosteroids 4 months prior to screen
• Concurrent Ocular Conditions:
• Any concurrent ocular condition in the study eye (e.g., cataract or age-related macular degeneration) that, in the opinion of the investigator could: require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or, if allowed to progress untreated, could likely contribute to a loss of at least 2 Snellen equivalent lines of BCVA over the study period
• Active intraocular inflammation (grade trace or above) in the study eye
• Current vitreous hemorrhage in the study eye
• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Aphakia or absence of the posterior capsule in the study eye
• Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
• Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
• History of glaucoma-filtering surgery in the study eye
• History of corneal transplant in the study eye
• High Risk PDR: New vessels within one disc diameter of the optic nerve head that are larger than one-third disc area
• Vitreous or preretinal hemorrhage associated with less extensive NVD or with NVE one-half disc area or more in size

Where it is running

• Retina Consultants of Houston — Houston, Texas, United States
• Retina Consultants of Houston — Katy, Texas, United States
• Retina Consultants of Houston — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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