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Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab
Phase 4 trial testing Intravitreal ranibizumab 0.3mg in Diabetic Macular Edema in 40 participants. Completed in 15 May 2017.
| Lead sponsor | California Retina Consultants |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 13 March 2015 |
| Primary completion | 15 May 2017 |
| Estimated completion | 15 May 2017 |
| Sites | 6 locations across United States |
California Retina Consultants — full company profile →
18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.
| Group | Value | 95% CI |
|---|---|---|
| Monthly | 161.94 | ± 43.56 |
| PRN Group | 167.65 | ± 32.30 |
To evaluate the mean change in activity impairment from baseline to 12 months using and activity impairment questionnaire. Scale is from 0-10 with 0 being lowest (no effect on my daily activities) and 10 being highest (completely prevented me from doing my daily activities).
| Group | Value | 95% CI |
|---|---|---|
| Monthly | -2.25 | ± 3.14 |
| PRN Group | -0.78 | ± 2.44 |
To determine the mean change in best-corrected visual acuity on ETDRS visual acuity chart at a starting distance of 4 meters from baseline. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.
| Group | Value | 95% CI |
|---|---|---|
| Monthly Intravitreal Ranibizumab 0.3mg | 17.42 | ± 15.13 |
| PRN Intravitreal Ranibizumab 0.3mg | 14.92 | ± 11.60 |
To measure the mean change in contrast sensitivity scores on Pelli-Robson charts from baseline. Scale in assessing the log of the contract sensitivity score (CS score) is from 0-2.25, with 0 being no letters read on the contrast sensitivity chart, and 2.25 being all letters read on the contrast sensitivity chart. Total CS score = \[(total # letters correct - 3) x 0.05\].
| Group | Value | 95% CI |
|---|---|---|
| Monthly | 0.39 | ± 0.45 |
| PRN Group | 0.26 | ± 0.40 |
Time frame: Through study completion, an average of 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Monthly | PRN Group |
|---|---|---|---|
| Myocardial infarction | Cardiac disorders | — | — |
| fractured humerus and tibia | Injury, poisoning and procedural complications | — | — |
| Septic Knee | Infections and infestations | — | — |
| stress, cardiomyopathy, acute renal disfunction | Cardiac disorders | — | — |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | — | — |
| lower back and abdominal pain | Gastrointestinal disorders | — | — |
| congestive heart failure | Cardiac disorders | — | — |
| Urinary Tract Infection with Sepsis | Renal and urinary disorders | — | — |
| Blurry Vision | Eye disorders | — | — |
| Reaction | System | Monthly | PRN Group |
|---|---|---|---|
| Flu/cold | Infections and infestations | — | — |
| Eye redness | Eye disorders | — | — |
| Upper respiratory infection | Reproductive system and breast disorders | — | — |
| Eye Pain | Eye disorders | — | — |
| Eye Itchiness (ocular pruitis) | Eye disorders | — | — |
| Floaters | Eye disorders | — | — |
| Blurry/distorted vision | Eye disorders | — | — |
| Allergies/ Congestion | Immune system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| leg injury | Injury, poisoning and procedural complications | — | — |
| Subconjunctival Hemorrhage | Eye disorders | — | — |
| Shingles | Infections and infestations | — | — |
| Photophobia | Eye disorders | — | — |
| Selective Laser Trabeculotomy | Surgical and medical procedures | — | — |
| Anxiety | General disorders | — | — |
| Insomnia | General disorders | — | — |
| fall | General disorders | — | — |
| herniea/hernia repair | Surgical and medical procedures | — | — |
| Cataract Extraction | Surgical and medical procedures | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | — | — |
| Heart Infection | Infections and infestations | — | — |
| Food Poisoning | Gastrointestinal disorders | — | — |
| Hospitalization for swelling and fluid | General disorders | — | — |
| Kidney stone | Renal and urinary disorders | — | — |
Most-reported serious reactions: Myocardial infarction, fractured humerus and tibia, Septic Knee, stress, cardiomyopathy, acute renal disfunction, Pulmonary Edema, lower back and abdominal pain, congestive heart failure, Urinary Tract Infection with Sepsis.
Data from ClinicalTrials.gov NCT02107131 adverse events section.
Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema (DME).
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing