An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial

Phase 3

Not yet recruiting

• Conditions: diabetic macular edema; swelling of the retina; 10047060

• Registration Number: NL-OMON33189
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Patients must have completed the RESTORE study assessments at Month 12
- Patients must give written informed consent before any study related activity of this extension protocol is performed.

Exclusion Criteria

- Ocular Conditions:
- Uncontrolled glaucoma in either eye
- Evidence of vitreomacular traction in either eye at visit 14
- Active proliferative diabetic retinopathy in the study eye at visit 14;Ocular treatments:
- Intravitreal corticosteroid treatment in a phakic study eye during the core study
- Intravitreal corticosteroids in post-cataract surgical study eye (aphakic or pseudophakic without damaged posterior capsule) within 3 months prior to Visit 14
- Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular corticosteroids at visit 14;Systemic conditions or treatments
- Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
- History of hypersensitivity to ranibizumab or any component of the ranibizumab
formulation
- Any type of advanced, severe or unstable disease or its treatment, that could interfere with primary and/or secondary outcome evaluations including any medical condition that could be expected to progress, recur, or change to such an extend that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
- History of stroke or transient ischemic attack (TIA);Complience / Administrative:
- Use of investigational drugs, other than those priovided in RESTORE study at the time of enrollment,
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, UNLESS they are using two birth control methods.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Inability to comply with study or follow-up procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study will be assessed based on the incidence and<br /><br>severity of treatment emergent ocular (presented separately for the study eye<br /><br>and the fellow eye) and non-ocular adverse events during the 24-month study<br /><br>period. </p><br>