Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-19

Study Completion Date

2015-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing

NCT02127684

Persistent Diabetic Macular Edema

WITHDRAWN PHASE2

Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

NCT00387582

Diabetic Retinopathy Diabetic Macular Edema

COMPLETED PHASE2

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

NCT01223612

Diabetic Retinopathy

COMPLETED PHASE4

A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema

NCT06305416

Diabetic Macular Edema Diabetic Retinopathy Macular Edema +3 more

RECRUITING PHASE3

Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema

NCT04387604

Diabetic Macular Edema

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a multicenteric, open-label, phase IIIb study, which comprised of 2 groups: the Main Group and the Rescue Group.

Patient's eligibility was assessed during a screening visit (Visit 1) which took place 14 days maximum before treatment initiation (Visit 2 \[Day 0\]). All patients were initially included in the Main Group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from Day 0 to Month 5, followed by 2 additional injections at Months 8 and 11). Patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). Their visual acuity was to be checked at each study visit (Months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. Patients who responded to treatment were maintained in the Main Group. Patients who did not meet pre defined criteria were moved to the Rescue Group and treated at the investigator's discretion.

The trial was terminated before any patient reached month 12.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Edema Macular Degeneration Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ranibizumab 0.5mg

Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Group Type EXPERIMENTAL

Ranibizumab 0.5mg

Intervention Type DRUG

Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ranibizumab 0.5mg

Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type I or type II diabetes with HbA1c≤10%
* Visual impairment due to a diabetic macular edema
* Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary