Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE)

Part of paid clinical trials in Houston, Texas.

Sponsor
David M. Brown, M.D.
Study ID
NCT01552408
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 0.3 mg ranibizumab — DRUG
    Cohort 1: Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
  • Targeted Pan Retinal Photocoagulation — PROCEDURE
    Cohort 2: Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan retinal photocoagulation (PRP) based on ultra wide 200º field angiography. After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.

Study Details

This study is a Phase I/II, multicenter, randomized, study of the efficacy and safety of ranibizumab injection monotherapy verses a duel therapy of 0.3mg ranibizumab combined with ultra wide, 200° field angiography guided pan retinal photocoagulation in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2).

Key Dates

First listed
Mar 13, 2012
Start date
Mar 31, 2012
Status verified
Oct 2018
Primary completion
May 18, 2017
Completion
May 18, 2017

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 0.3 mg Ranibizumab
    Cohort 1: Subjects will receive 4 IVT of 0.3 mg ranibizumab every 28 days (+/- 7 days), then will be seen monthly (+/- 7 days) \& will receive IVT of 0.3 mg ranibizumab on a pro re nata (PRN) schedule per retreatment criteria.
  • Experimental: Targeted PRP with 0.3 mg Ranibizumab
    Cohort 2: Subjects will receive 4 it of 0.3 mg ranibizumab every 28 days (+/- 7 days), then will then be seen monthly (+/- 7 days) \& receive IVT of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at Day 7 they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide field angiography. Ultra wide field angiography will be performed every 3 months to indicate areas of peripheral ischemia, which will be selectively be treated with PRP at Month 6, Month 18, and Month 25, preserving areas of more perfused retina.

Primary Outcome Measure

Total Number of Ranibizumab Injections in Each of the Two Cohorts in a 36 Month Period [ Time Frame: 36 Months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Retina Consultants of HoustonHoustonTexas77030-
Retina Consultants of HoustonKatyTexas77494-
Retina Consultants of HoustonThe WoodlandsTexas77384-

Find similar trials in Houston, TX

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Consultants of Houston· Houston, TXRetina Consultants of Houston· Katy, TXRetina Consultants of Houston· The Woodlands, TX

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