Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation

NCT01223612 | Completed Phase 4 DMC

• 1 other identifier: HYKP1015
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study will compare the effects of ranibizumab treatment with conventional macular laser therapy for patients with diabetic macular oedema. The study hypothesises that treatment with ranibizumab may be superior to laser treatment in terms of improving vision and decreasing retinal thickness. Patients will be randomised to receive either repeated injections of ranibizumab every 4 weeks for 48 weeks or macular laser therapy every 12 weeks for 48 weeks. At baseline, and then at 12, 24 and 48 weeks, patients will undergo detailed testing to provide information on the structure and function of the retina with both of these treatments.

Conditions

Diabetic Retinopathy

Keywords

Diabetes Mellitus; Diabetes Complications; Retinal Diseases; Edema; Endothelial Growth Factors; Monoclonal Antibodies; Ranibizumab; Laser therapy

Outcome Measures

Primary Outcomes (1)

• Functional and anatomical change in the retina

  This is an exploratory study. The primary outcome measure is the change in retinal function and anatomy at 48 weeks compared to baseline, as assessed by fluorescein angiography, microperimetry and electrophysiological testing.

  48 weeks

Secondary Outcomes (2)

• Mean ETDRS acuity

  48 weeks

• OCT macular thickness

  48 weeks

Study Arms (2)

Ranibizumab

EXPERIMENTAL

Intravitreal injection of ranibizumab

Drug: Ranibizumab

Laser

ACTIVE COMPARATOR

Modified ETDRS laser

Procedure: Modified ETDRS laser

Interventions

Ranibizumab DRUG

Intravitreal injection of 0.5mg in 0.05ml. One injection at baseline, 4 and 8 weeks then four-weekly as required to 44 weeks.

Also known as: Lucentis

Ranibizumab

Modified ETDRS laser PROCEDURE

Argon laser therapy to the macula in accordance with the modified ETDRS protocol at baseline, 12, 24 and 36 weeks.

Also known as: Argon laser photocoagulation

Laser

Eligibility Criteria

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

You may qualify if:

• Diagnosis of diabetes mellitus (type 1 or type 2)
• Retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield ≥ 300 microns
• Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent ≥ 6/24 and ≤ 6/9)
• Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
• Intraocular pressure less than 30 mmHg
• Ability to return for study visits
• Visual acuity in fellow eye ≥ 2/60
• Fellow eye has received no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months
• No previous laser within 3 months of randomisation
• Ability to give informed consent throughout the duration of the study

You may not qualify if:

• Macular ischaemia
• Macular oedema from a cause other than diabetic macular oedema
• Co-existent ocular disease
• Presence of an ocular condition such that visual acuity would not improve from resolution of macular oedema
• Presence of an ocular condition that might affect macular oedema or alter visual acuity during the course of the study
• A substantial cataract that is likely to be decreasing visual acuity by 3 lines or more
• History of treatment for diabetic macular oedema at any time in the past 3 months
• History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation
• Anticipated need for PRP in the 6 months following randomisation.
• Proliferative diabetic retinopathy in the study eye.
• A condition that, in the opinion of the investigator, would preclude participation in the study.
• Haemoglobin A1c \> 11.0 %
• A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
• Blood pressure \>170/100 mmHg
• Myocardial infarction, other cardiac event requiring hospitalisation, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• Novartis: collaborator

Study Sites (1)

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus; Diabetes Complications; Retinal Diseases; Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Philip G Hykin, FRCS FRCOphth

  Moorfields Eye Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

GB (1)