Widefield Angiography Guided Targeted-retinal Photocoagulation Combined With Anti VEgf Intravitreal Injections for the Treatment of Ischemic Central Retinal Vein Occlusion, Hemi Retinal Vein Occlusion, and Branch Retinal Vein Occlusion

NCT01710839 | Completed Phase 4 Results

• 1 other identifier: 12246
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central retinal vein occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to standard of care

Conditions

Central Retinal, Hemi Retinal & Brach Retinal Vein Occlusions

Keywords

CRVO; BRVO; HRVO; Macular edema; vein occlusion

Outcome Measures

Primary Outcomes (2)

• Total Number of Intravitreal Injections Over a 12 Month Period

  Assess the number of intravitreal injections over 12 months.

  12 months

• Visual Acuity

  Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.

  12 month period

Secondary Outcomes (7)

• Retinal Ischemia

  12 month period

• Foveal Avascular Zone

  12 months

• Adverse Events

  12 months

• Neovascularization of the Iris, Optic Nerve and Elsewhere

  12 months

• Central Foveal Outcome

  12 months

Study Arms (2)

Targeted Pan Retinal laser combined with 0.5mg ranibizumab

EXPERIMENTAL

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

Drug: 0.5mg Ranibizumab; Procedure: Targeted Pan Retinal Photocoagulation

Ranibizumab 0.5mg

ACTIVE COMPARATOR

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

Drug: 0.5mg Ranibizumab

Interventions

0.5mg Ranibizumab DRUG

intravitreal injections

Also known as: Lucentis

Ranibizumab 0.5mg; Targeted Pan Retinal laser combined with 0.5mg ranibizumab

Targeted Pan Retinal Photocoagulation PROCEDURE

Targeted Pan Retinal Photocoagulation based on wide field angiography

Also known as: PRP, Pan Retinal Photocoagulation, TRP, Pan Laser

Targeted Pan Retinal laser combined with 0.5mg ranibizumab

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Visual acuity between 20/25 and 20/800, ETDRS best corrected visual acuity
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Patients previously treated with any ITV anti-VEGF:
• With at least 2 consecutive monthly intravitreal injections of anti-VEGF medications with presence of persistent or recurrent macular edema in the past 4 months

You may not qualify if:

• IOP over 30 mm Hg
• Any previous retinal laser photocoagulation to the study eye
• Previous intravitreal injection in the study eye of any corticosteroid treatment
• Previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery)
• Intracapsular cataract extraction
• Any previous radiation treatments to head/neck that the principal or sub investigator feels is clinically relevant
• Inability to assess iris or angle neovascularization (corneal opacity precluding gonioscopy)
• Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study
• Significant diabetic retinopathy in the fellow eye (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy)
• Participation in another simultaneous medical investigator or trial
• Ocular disorders or concurrent disease in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention, including history of retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., DME, AMD, ocular histoplasmosis, or pathologic myopia)
• Structural damage to the center of the macula in the study eye prior to CRVO, HRVO and BRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s)
• Vitreomacular traction or clinically significant epiretinal membrane in the study eye evident biomicroscopically or by OCT (vitreomacular attachment OK)
• Infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection
• Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia (For patients who have had refractive or cataract surgery in the study eye, preoperative spherical equivalent refractive error of more than -8 diopters myopia is not allowed)

Sponsors & Collaborators

• Charles C Wykoff, PhD, MD: lead
• Genentech, Inc.: collaborator

Study Sites (3)

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 (14)

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  PMID: 2483144 BACKGROUND

• Fan W, Fleming A, Hemert JV, Wykoff CC, Brown DM, Robertson G, Wang K, Falavarjani KG, Sadda SR, Ip M. RETINAL VASCULAR BED AREA IN EYES WITH RETINAL VEIN OCCLUSION ON ULTRA-WIDEFIELD FLUORESCEIN ANGIOGRAPHY: WAVE Study. Retina. 2022 Oct 1;42(10):1883-1888. doi: 10.1097/IAE.0000000000003549.

  PMID: 35976232 DERIVED

• Wykoff CC, Ou WC, Wang R, Brown DM, Cone C, Zamora D, Le RT, Sagong M, Wang K, Sadda SR; WAVE Study Group. Peripheral Laser for Recalcitrant Macular Edema Owing to Retinal Vein Occlusion: The WAVE Trial. Ophthalmology. 2017 Jun;124(6):919-921. doi: 10.1016/j.ophtha.2017.01.049. Epub 2017 Mar 18. No abstract available.

  PMID: 28318636 DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

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: Charles C Wykoff, PhD, MD
• Organization: Retina Consultants of Houston

ccwmd@houstonretina.com

713-524-3434

Study Officials

• Charles C Wykoff, PhD, MD

  Retina Consultants Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Research

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 8, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-08

Locations

US (3)