A study to find out treatment responders in Diabetic macular edema

Phase 4

• Conditions: Health Condition 1: null- Diabetic macular edemaHealth Condition 2: H36- Retinal disorders in diseases classified elsewhere

• Registration Number: CTRI/2017/01/007630
• Lead Sponsor: Dr Gopal S Pillai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022
• Study Completion: 2023-08-02

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1)Male or female patients >18 years of age who have signed an informed consent

2)Type II DM with centre involving DME

3)Best corrected Visual acuity (BCVA) 20/30 to 20/200 (6/9 to 6/60 Snellen )

4)Central Macular thickness more than 300 microns

5)Medication for the management of diabetes must have been stable within 3 months prior to screening and is expected to remain stable during the course of the study.

Exclusion Criteria

1)Exclusion criteria will comply with local label

2)Other progressive retinal diseases

3)Active intraocular inflammation (grade trace or above) in either eye or any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye

4)Media opacities which prevents good documentation

5)Uncontrolled glaucoma in either eye (e.g. IOP > 24 mmHg on medications, or according to investigatorââ?¬•s judgement)

6)Neovascularization of the iris in either eye

7)Evidence of vitreomacular traction in either eye

8)Previous vitrectomy

9)Recent cataract surgery within 3 months or Pan-retinal laser photocoagulation in the study eye within 6 months or Focal/grid laser photocoagulation in the study eye within 3 months prior to screening

10)Recent intravitreal injection within 3 months (e.g. - pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, corticosteroids etc.)

11)History of stroke , heart attack or any other thrombo embolic event within the last 6 months.

12)Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl

13)Untreated diabetes mellitus

14)Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg and Untreated or uncontrolled hypertension

15)Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol

16) Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation or fluorescein

17)Any type of advanced, severe or unstable disease or its treatment, that could interfere with primary and/or secondary outcome evaluations

18)Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to randomization

19)Inability to comply with study or follow-up procedures.

20)Pregnant or nursing (lactating) women

21)Any type of systemic disease or its treatment, including any medical condition (controlledor uncontrolled) that could be expected to progress, recur, or change to such an extent thatit may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of patients with VEGF reactivity belonging to responders and non responders following RanibizumabTimepoint: 6months

Secondary Outcome Measures

Name	Time	Method
Identification of novel markers that may predict the conversion from Non proliferative diabetic retinopathy to Proliferative diabetic retinopathy as well as at the various stages of disease progressionTimepoint: 6months