Phase 2
N=40
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.
Radiation Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT02222610 ↗Enrolled (actual)
40
Serious AEs
20.0%
Results posted
Mar 2021
Primary outcome: Primary: Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. — -1.9; -3.9; 1.3 letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.5 mg ranibizumab (Drug); Targeted Retinal Photocoagulation (TRP) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Greater Houston Retina Research
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. |
-1.9; -3.9; 1.3 | — |
| SECONDARY The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. |
22.2; 18.5; 16.1 | — |
| SECONDARY Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. |
1; 0; 3 | — |
| SECONDARY Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104. |
1; 2; 5 | — |
| SECONDARY Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline. |
-8.5; -87; -74.6 | — |
Summary
The purpose of this study is to assess the tolerability and efficacy of ranibizumab treatment administered in subjects with radiation retinopathy
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
- History of corneal transplant in the study eye
- Uncontrolled blood pressure (defined as systolic and/or diastolic > 180/110 mmHg while subject is seated). If the subject's initial reading exceeds these values, a second reading may be taken at least 30 minutes later. If the subject requires antihypertensive medication, the subject can become eligible if medication is taken continuously for at least 14 days prior to Day 0 and blood pressure is less that 180/110 mmHg.
- New diagnosis of atrial fibrillation not managed by subject's primary care physician or cardiologist within 3 months of Day 0.
- History of stroke within the last 3 months of Day 0.
- History of myocardial infarction within 3 months of Day 0.
- History of other disease, metabolic dysfunction, or physical exami
Data sourced from ClinicalTrials.gov (NCT02222610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.