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.

NCT02222610 | Completed Phase 2 Results

• 1 other identifier: ML29236
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Radiation Retinopathy

Keywords

Radiation Retinopathy

Outcome Measures

Primary Outcomes (1)

• Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0.

  Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart.

  104 weeks

Secondary Outcomes (4)

• The Mean Number of Intravitreal Injections Required Per Subject Per Cohort.

  104 weeks

• Percentage of Subjects With Retinal Hemorrhage at 104 Weeks.

  104 weeks

• Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104.

  104 weeks

• Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline.

  104 weeks

Study Arms (3)

Cohort A

EXPERIMENTAL

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.

Drug: 0.5 mg ranibizumab

Cohort B

EXPERIMENTAL

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.

Drug: 0.5 mg ranibizumab; Procedure: Targeted Retinal Photocoagulation (TRP)

Cohort C

EXPERIMENTAL

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.

Drug: 0.5 mg ranibizumab; Procedure: Targeted Retinal Photocoagulation (TRP)

Interventions

0.5 mg ranibizumab DRUG

Also known as: Lucentis

Cohort A; Cohort B; Cohort C

Targeted Retinal Photocoagulation (TRP) PROCEDURE

TRP to areas of retinal ischemia

Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Greater Houston Retina Research: lead
• Genentech, Inc.: collaborator

Study Sites (4)

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston/The Medical Center

Houston, Texas, 77030, United States

Location

Retina Consultants of Houston

Katy, Texas, 77494, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Related Publications (21)

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  PMID: 34463842 DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Amy C. Schefler
• Organization: Retina Consultants of Texas

acsmd@retinaconsultantstexas.com

(713) 524-3434

Study Officials

• Amy C Schefler, MD

  Retina Consultants Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 21, 2014
• Study Start: September 23, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 25, 2021
• Results First Posted: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)