A 12 month, open label, multi-center study to evaluate the efficacy and safety of intravitreal injections of ranibizumab 0.5 mg on Cystoid, Spongy & Mixed OCT patterns secondary to Diabetic Macular Edema (DME)

Phase 4

• Conditions: Health Condition 1: null- Patients with Cystoid, Spongy & Mixed OCT patterns secondary to Diabetic Macular Edema (DME)

• Registration Number: CTRI/2014/02/004379
• Lead Sponsor: Dr V Narendran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1.Patients must be >=18 years of age who have signed an informed consent.

2.Having Type 1 or Type 2 diabetes mellitus.

3.Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.

4.BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160).

5.Retinal thickness >250 µm by OCT.

6.OCT scan acquisition possible.

Exclusion Criteria

A) Presence of Ocular concomitant conditions/ diseases

1.Active intraocular inflammation (grade trace or above) in either eye.

2.Any active infection (e.g. keratitis, scleritis, uveitis, endophthalmitis) in either eye

3.History of uveitis in either eye.

4.Structural damage within 0.5 disc diameter of the center of the macula in the study eye, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques.

5.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 cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia).

6.Uncontrolled glaucoma in either eye.

7.Neovascularization of the iris in either eye.

8.Evidence of vitreomacular traction in either eye.

9.Active proliferative diabetic retinopathy in the study eye (active PDR means below)

-patients who need a PRP(panretinal photocoagulation) treatment immediately

-patients with pre-retinal hemorrhage

-patients with vitreous hemorrhage

B)Received Ocular treatments as noted below:

1.Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study

2.Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry

3.Treatment with anti-angiogenic drugs in study eye within 3 months

4.Any intraocular surgery in the study eye within 3 months or planned during trial duration

5.History of vitrectomy in study eye

6.History of intravitreal corticosteroid treatment in phakic study eye

7.Intravitreal corticosteroids in post-cataract surgery study eye (aphakic or pseudophakic, without damaged posterior capsule) within 3 months

C)Systemic conditions or treatments

1.History of stroke

2.Untreated diabetes mellitus: HbA1C level12

3.Untreated or uncontrolled hypertension: SBP 160mmHg or DBP100mmHg

4.Pregnant or nursing (lactating) women

5.Inability to comply with study or follow-up procedures

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of intravitreal injections of ranibizumab (Lucentis®) 0.5 mg in the management of different Diabetic Macular Edema morphological variants as assessed by mean change from baseline in Best Corrected Visual Acuity (BCVA) on Early Treatment Diabetic Retinopathy Study (ETDRS) chart over a 12 month treatment period.Timepoint: Outcome will be assessed at Day 0, Day 1, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, week 28, week 32, week 36, week 40, week 44 and week 48.

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the mean change of Best corrected Visual acuity on ETDRS after intravitreal injections of ranibizumab (Lucentis®) 0.5 mg on a monthly basis. <br/ ><br>2.To evaluate the change in Central Retinal Thickness (CRT) of different variants of Diabetic Macular Edema and morphology on Optical Coherence Tomography (OCT) after intravitreal injections of ranibizumab 0.5 mg on a monthly basis. <br/ ><br>3.To evaluate the safety (ocular and non ocular) of intravitreal injections ranibizumab 0.5 mg. <br/ ><br>Timepoint: On monthly basis