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

December 26, 2008
November 1, 2011
February 2008
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00815360 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ranibizumab and PRP in Patients With CSDME and Peripheral Nonperfusion
Ranibizumab (rhuFab V2) and Scatter Laser Photocoagulation in Treatment of Patients With Clinically-significant Diabetic Macular Edema With Peripheral Retinal Nonperfusion (RaScaL)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Macular Edema
  • Other: intravitreal injection of ranibizumab + peripheral laser
    a single injection of 0.5 mg ranibizumab plus wide field peripheral laser
    Other Name: treatment arm
  • Drug: triamcinolone acetate
    4 mg/0.1 cc triamcinolone acetate
    Other Name: control arm 1
  • Other: intravitreal injection of triamcinolone and macular laser
    4 mg/0.1 cc triamcinolone acetate plus macular focal laser
    Other Name: control group 2
  • Active Comparator: Treatment group 1
    ranibizumab and scatter laser
    Intervention: Other: intravitreal injection of ranibizumab + peripheral laser
  • Comparative group 1
    Intravitreal triamcinolone acetate
    Intervention: Drug: triamcinolone acetate
  • Comparative Group 2
    Intravitreal triamcinolone with macular laser
    Intervention: Other: intravitreal injection of triamcinolone and macular laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00815360
Pro00002813, Duke SPS#150894
No
Ivan J. Suner, MD, Retina Associates of Florida, P.A.
Retina Associates of Florida, P.A.
Not Provided
Principal Investigator: Ivan J Suner, MD Duke University Health System
Retina Associates of Florida, P.A.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP