Study of the Efficacy and Tolerability of Intravitreal Injections of Ranibizumab Compared to Intravitreal Injections of Ranibizumab Combined With Targeted Retinal Photocoagulation to Treat Radiation Retinopathy.

Completed · Phase 2

Conditions studied: Radiation Retinopathy

In brief

The purpose of this study is to assess the tolerability and efficacy of ranibizumab treatment administered in subjects with radiation retinopathy

Key facts

Study ID

NCT02222610

Run by

Greater Houston Retina Research

People needed

40

Starts

2014-09-23

Expected to finish

2019-03-01

Last updated by the study team

2021-03-25

Who can join

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

You may qualify if…

• Subjects will be eligible to participate if the following criteria are met:
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 18 years
• Active radiation retinopathy resulting from any form of radiation treatment performed within the last 3 years. Radiation retinopathy is defined as any of the following: retinal hemorrhages, exudates, edema, and/or neovascularization, not attributable to other causes.
• Best Corrected Visual Acuity (BCVA) of 20/25-20/400 in the study eye

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from this study:
• Pregnancy (verified by positive pregnancy test) or lactation
• Premenopausal women not using adequate methods of contraception. The following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
• Participation in any other simultaneous medical investigation or trial
• Previous participation in any studies involving investigational drugs within 30 days before Day 0 (excluding vitamins and minerals).
• History of allergy fluorescein, not amenable to treatment
• Previous intravitreal treatment with any anti-vascular endothelial growth factor (VEGF) drug within 60 days of Day 0
• Previous intravitreal or subconjunctival treatment with cortical steroids within 90 days of Day 0
• History of vitrectomy
• History of treatment with more than one form of radiation to the eye (e.g. proton beam therapy and plaque therapy).
• Subjects who have more than 7 disc diameters of ischemia in the central macula that would hinder visual acuity improvement
• History of panretinal photocoagulation treatment in the study eye.
• Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed
• Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could:
• Require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition.
• Contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period, if allowed to progress untreated.
• Active intraocular inflammation (grade 2+ 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 intraocular pressure (IOP) > 30 mmHg despite treatment with anti-glaucoma medication).
• History of glaucoma-filtering surgery in the study eye

Where it is running

• Texas Retina Associates — Dallas, Texas, United States
• Retina Consultants of Houston/The Medical Center — 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

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.