Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion

NCT00815360 | Completed Phase 2 Results

• 1 other identifier: Pro00002813
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a combination of ultrawide-field angiography (UWFA) and optical coherence tomography (OCT). Within this classification scheme, patients with CSME are subdivided by the presence of: 1) focal macular leakage, 2) vitreomacular interface traction, and/or 3) peripheral nonperfusion. The successful treatment of diabetic macular edema would be dictated by pathophysiology-directed therapy based on this classification. The subgroup of interest for this clinical trial is characterized by diabetic macular edema, peripheral nonperfusion on UWFA, and the absence of macular traction on OCT. This group of patients has previously not been well recognized or characterized due to limitations in previous, standard angiographic evaluation of the retinal periphery. We postulate that this subcategory represents one with a high rate of failure of accepted therapies given persistence of the basic pathophysiologic mechanism for CSME, namely ischemia-induced production of Vascular Endothelial Growth Factor (VEGF) from the retinal periphery. This also represents a population of patients with likely recurrence of CSME despite treatment with anti-VEGF therapy alone for the same reason.

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.

  6 months

Secondary Outcomes (1)

• Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months

  6 months

Study Arms (2)

Treatment group

EXPERIMENTAL

1. single intravitreal injection of ranibizumab (0.5 mg in 0.1 cc) 2. peripheral laser to areas of retinal nonperfusion on ultra-widefield fluorescein angiography

Drug: intravitreal injection of ranibizumab; Procedure: peripheral laser

Control Group

ACTIVE COMPARATOR

1. single intravitreal injection of triamcinolone acetonide (4.0 mg in 0.1 cc) 2. macular laser per treatment criteria

Drug: intravitreal injection of triamcinolone acetonide; Procedure: macular laser

Interventions

intravitreal injection of ranibizumab DRUG

intravitreal injection of 0.5 mg ranibizumab

Also known as: treatment arm

Treatment group

peripheral laser PROCEDURE

ultra-widefield fluorescein angiography guided peripheral laser

Also known as: treatment arm

Treatment group

intravitreal injection of triamcinolone acetonide DRUG

intravitreal injection of 4.0 mg triamcinolone acetonide

Also known as: control arm

Control Group

macular laser PROCEDURE

macular laser to areas of retinal thickening or leakage

Also known as: control arm

Control Group

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 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
• Patient related considerations:
• Patients with Type I or Type II diabetes
• Disease related considerations:
• Study eye with clinically significant diabetic macular edema characterized by macular edema, peripheral nonperfusion, and absence of macular traction on clinical exam, UWFA, and OCT.
• Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart and 20/320 (≥ 19 letters on ETDRS chart) Other considerations
• Patient able to complete all study visits
• Female patients must be using two forms of contraception

You may not qualify if:

• Pregnancy (positive pregnancy test) or lactation. Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an Intra Uterine Device, or contraceptive hormone implant or patch.
• Prior enrollment in the study
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial
• Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months
• Previous panretinal scatter laser photocoagulation
• Previous pars plana vitrectomy
• Visually-significant significant cataracts as primary reason for vision loss
• Uncontrolled or advanced glaucoma
• Patients on more than one anti-glaucoma agent
• Myocardial infarction or cerebrovascular accident within 6 months
• Subjects with poor glycemic control that have initiated intensive insulin treatment or plan to do so in the next 4 months

Sponsors & Collaborators

• Retina Associates of Florida, P.A.: lead

Study Sites (1)

Retina Associates of Florida

Tampa, Florida, 33609, United States

Location

Limitations and Caveats

small study size

Results Point of Contact

• Title: Dr. Ivan J. Suner
• Organization: Retina Associates of Florida, P.A.

ivansuner@gmail.com

813-875-6373

Study Officials

• Ivan J Suner, MD

  Retina Associates of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 30, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 5, 2015
• Results First Posted: March 5, 2015

Record last verified: 2014-10

Locations

US (1)