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Ranibizumab and PRP in Patients With CSDME and Peripheral Nonperfusion (RaScaL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier:
NCT00815360
First received: December 26, 2008
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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 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.


Condition Intervention Phase
Diabetic Macular Edema
 Other: intravitreal injection of ranibizumab + peripheral laser
Drug: triamcinolone acetate
Other: intravitreal injection of triamcinolone and macular laser
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ranibizumab (rhuFab V2) and Scatter Laser Photocoagulation in Treatment of Patients With Clinically-significant Diabetic Macular Edema With Peripheral Retinal Nonperfusion (RaScaL)

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Retina Associates of Florida, P.A.:

Primary Outcome Measures:
  • 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 months 1, 3, and 6. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients gaining 15 letters or more from baseline to months 1, 3, and 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2008
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment group 1
ranibizumab and scatter laser
 Other: intravitreal injection of ranibizumab + peripheral laser
a single injection of 0.5 mg ranibizumab plus wide field peripheral laser
Other Name: treatment arm
Comparative group 1
Intravitreal triamcinolone acetate
 Drug: triamcinolone acetate
4 mg/0.1 cc triamcinolone acetate
Other Name: control arm 1
Comparative Group 2
Intravitreal triamcinolone with macular laser
 Other: intravitreal injection of triamcinolone and macular laser
4 mg/0.1 cc triamcinolone acetate plus macular focal laser
Other Name: control group 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 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

Exclusion Criteria:

  • 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 IUD, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815360

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Retina Associates of Florida, P.A.
Investigators
Principal Investigator: Ivan J Suner, MD Duke University Health System
  More Information

No publications provided

Responsible Party: Ivan J. Suner, MD, Director of Clinical Research, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier: NCT00815360     History of Changes
Other Study ID Numbers: Pro00002813, Duke SPS#150894
Study First Received: December 26, 2008
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Associates of Florida, P.A.:
diabetic macular edema

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013