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.
Condition: Radiation Retinopathy
MeSH terms: Retinal Diseases
Intervention: 0.5 mg ranibizumab; Targeted Retinal Photocoagulation (TRP)
Intervention description: TRP to areas of retinal ischemia
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Radiation Retinopathy

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 examination finding
             giving reasonable suspicion of a disease or condition that contraindicates the use of
             an investigational drug or that might affect interpretation of the results of the
             study or renders the subject at high risk for treatment complications.

          -  Current treatment for active systemic infection

          -  Active malignancy other than uveal melanoma

          -  Presence of metastases