Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement
Completed · Phase 2
Conditions studied: Diabetic Retinopathy
In brief
The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.
Key facts
- Study ID
- NCT03531294
- Run by
- Greater Houston Retina Research
- People needed
- 40
- Starts
- 2018-05-23
- Expected to finish
- 2021-04-09
- Last updated by the study team
- 2021-05-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or Women > 18 years of age with type 1 or II diabetes mellitus
- Diabetic Retinopathy, DRSS Level 47A to 71A, as assessed by CRC (enrollment of PDR levels will be limited to 50% of the total population)
- BCVA in the study eye better than 20/800
You may not qualify if…
- Any prior systemic anti-VEGF treatment or IVT anti-search vascular endothelial growth factor (VEGF) treatment in the study eye within 24 weeks of screening/baseline
- Any intravitreal or peribulbar corticosteroids in the study eye within 12 weeks of screening/baseline
- Any prior treatment with Ozurdex or Iluvien in the study eye
- SD-OCT central subfield thickness (CST) > 320 µm in the study eye
- Central DME causing visual acuity loss, in which treatment can not be safely deferred for at least 6 months, in the investigator's judgment
- Current visually significant vitreous hemorrhage in the study eye. Vitreous hemorrhage is allowed as long as DRSS level is 71A or lower.
- History of panretinal photocoagulation (PRP) in the study eye
- History of vitrectomy surgery in the study eye
- Cataract surgery in the study eye within 8 weeks of screening/baseline
- Pregnant or breast-feeding women
- Sexually active men* or women of childbearing potential** who are unwilling to practiceadequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/baseline; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
- Contraception is not required for men with documented vasectomy.
- * Postmenopausal women must be amenorrheic for at least 52 weeks in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
- If currently receiving diaylisis, must have started treatment more than 12 weeks prior to screening/baseline
- Uncontrolled blood pressure (defined as > 190/110 mm Hg systolic/diastolic, while seated)
Where it is running
- Retina Consultants of Houston/The Medical Center — Houston, Texas, United States
- Retina Consultants of Houston — The Woodlands, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.