Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema

NCT02131350 | Completed Phase 4 DMC

• 1 other identifier: 2617
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.

Conditions

Diabetic Macula Edema

Outcome Measures

Primary Outcomes (1)

• best corrected visual acuity

  Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.

  every month, up to 36 months

Study Arms (1)

Ranibizumab with Photocoagulation

EXPERIMENTAL

Procedure: Photocoagulation; Drug: Ranibizumab

Interventions

Photocoagulation PROCEDURE

Photocoagulation include focal/grid laser and/or panretinal photocoagulation

Ranibizumab with Photocoagulation

Ranibizumab DRUG

Ranibizumab with Photocoagulation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable medication for the management of diabetes within 3 months
• visual impairment due to focal or diffuse diabetic macula edema
• decreased vision due to diabetic macula edema and not other causes

You may not qualify if:

• concomitant conditions in the study eye that could prevent the improvement in VA on the study
• active intraocular inflammation or infection in either eye
• uncontrolled glaucoma in either eye
• treatment with antiangiogenic drugs in the study eye within 3 months
• history of stroke and uncontrolled hypertension

Sponsors & Collaborators

• Shinshu University: lead

Study Sites (1)

Department ou Ophthalmology Shinshu University School of Medicine

Matsumoto, Nagano, 3908621, Japan

Location

MeSH Terms

Interventions

Light Coagulation; Ranibizumab

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Hemostasis, Surgical; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Ophthalmology Shinshu University School of Medicine

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: May 6, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

JP (1)