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.

Conditions

• Radiation Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 0.5 mg ranibizumab — DRUG
• Targeted Retinal Photocoagulation (TRP) — PROCEDURE
  TRP to areas of retinal ischemia

Study Details

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

Key Dates

First listed

Aug 21, 2014

Start date

Sep 23, 2014

Status verified

Mar 2021

Primary completion

Mar 31, 2019

Completion

Mar 31, 2019

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A
  Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks. Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on spectral domain (SD)-optical coherence tomography (OCT). The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
• Experimental: Cohort B
  Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
• Experimental: Cohort C
  Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.

Primary Outcome Measure

Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. [ Time Frame: 104 weeks ]

Locations (4)

Find similar trials in Dallas, TX

Related Studies

• Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
  PHASE3 · Recruiting · Jaeb Center for Health Research · Palo Alto, California