To Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus

NCT03495765 | Completed Phase 3 DMC

• 1 other identifier: Control1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes using an PRN treatment schedule.

Conditions

Diabetic Macular Oedema

Keywords

Diabetic macular oedema; Lucentis

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 12.

  12 months

Study Arms (2)

Well controlled

ACTIVE COMPARATOR

Eligibile people with diabetic macular oedema and HBA1C \< 7.5

Drug: Ranibizumab

Poorly controlled

ACTIVE COMPARATOR

eligible people with Diabetic macular oedema and HBAIC \>10.0

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Ranibizumab 0.5mcg via intravitreal injection to study eye up to monthly

Also known as: Lucentis

Poorly controlled; Well controlled

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with diabetes \> 21 years of age who have signed an informed consent
• Patients with either Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c levels either \< 7.5% or ≥ 10.0% at screening (visit 1) as measured within the last 3 months.
• Patients with visual impairment due to either focal or diffuse DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. The study eye must fulfill the following criteria at Visit 1 (if both eyes are eligible, the study eye will be selected by the investigator, based on potential for improvement): i) BCVA score between 73 and 39 letters, inclusively, using LogMAR visual acuity testing charts at 4 metres (or at the equivalent appropriate testing distance for the chart size) (approximate Snellen equivalent between 6/12 (20/40) and 6/48 (20/160); ii) the decrease in vision is due to DME but not due to other causes, in the opinion of the investigator
• OCT foveal centre point thickness ≥ 350µm on Spectral Domain OCT (≥300 µm on Time domain OCT / STRATUS)
• Medication for the management of diabetes should have been stable within the 3 months prior to randomisation

You may not qualify if:

• Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
• Active intraocular inflammation (grade trace or above) in either eye
• Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
• History of uveitis in either eye
• Structural damage within 1 disc diameter of the center of the macula in the study eye likely to preclude an improvement in visual acuity following the resolution of macular oedema, including (geographic) atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized hard exudates plaques
• Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period, including retinal vascular occlusion, retinal detachment, epiretinal membrane, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia)
• Uncontrolled glaucoma in the study eye (according to investigator's judgment)
• Neovascularization of the iris in study eye
• Evidence of vitreomacular traction in study eye, shown either clinically or on OCT
• Panretinal laser photocoagulation in the study eye within 6 months (in order to exclude patients with active proliferative disease) or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
• Treatment with anti-angiogenic drugs: pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, aflibercept (VEGF-Trap) within 3 months to study eye
• Intravitreal corticosteroids in either eye within 6 months prior to randomisation
• Any intraocular surgery in the study eye within 3 months prior to randomisation
• History of vitrectomy in study eye
• Phakic study eye with a history of intravitreal corticosteroid treatment (due to the likely late increase in secondary cataract)

Sponsors & Collaborators

• Marsden Eye Specialists: lead

Study Sites (1)

Marsden Eye Specialists

Paramatta, New South Wales, 2150, Australia

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 12, 2018
• Study Start: March 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

AU (1)