Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema

Allegro Ophthalmics

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Luminate 1.0mg; Drug: Luminate 3.0mg; Drug: Luminate 2.0mg; Drug: Avastin; Drug: Luminate 0.5mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02348918

DME 202B

Details and patient eligibility

About

A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema

Full description

To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema

• Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months).

Stage 2 (select sites): 75 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of Luminate intravitreal injection or Avastin intravitreal injection (0.5 mg and 1.0 mg). Subjects will be followed monthly for 20 weeks (5 months).

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years of age or older.

• Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT

• Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.

• Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.

• In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.

• Intra-Ocular Pressure (IOP) is under control (i.e., IOP

  ≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.

• Willing and able to return for all study visits.

• Able to meet the extensive post-op evaluation regimen.

• Understands and signs the informed consent form.

Exclusion criteria

• Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.
• Uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
• Screening HgA1c blood test > 10.0
• Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.
• A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.
• History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.
• Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.
• Previous pars plana vitrectomy in the study eye
• Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.
• YAG laser treatment in the study eye in last 30 days prior to study enrollment.
• High myopia in the study eye, with a spherical equivalent of >8.00D at screening
• Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.
• Chronic or recurrent uveitis.
• Ongoing ocular infection or inflammation in either eye.
• A history of cataract surgery complications/vitreous loss in the study eye.
• Congenital eye malformations in the study eye.
• A history of penetrating ocular trauma in the study eye.
• Mentally handicapped.
• Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.
• Nursing female.
• Currently participating in any other clinical research study.
• Contraindication to the study medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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218 participants in 9 patient groups

Luminate 1.0mg group

Active Comparator group

Description:

Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.

Treatment:

Drug: Luminate 1.0mg

Luminate 2.0mg group

Active Comparator group

Description:

Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.

Treatment:

Drug: Luminate 2.0mg

Luminate 3.0mg group

Active Comparator group

Description:

Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.

Treatment:

Drug: Luminate 3.0mg

Avastin® group

Active Comparator group

Description:

Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.

Treatment:

Drug: Avastin

Avastin then Luminate 1.0 mg IVT + sham injection

Active Comparator group

Description:

Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Treatment:

Drug: Avastin

Drug: Luminate 1.0mg

Avastin then Luminate 0.5 mg IVT + sham injection

Active Comparator group

Description:

Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Treatment:

Drug: Luminate 0.5mg

Drug: Avastin

Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT

Active Comparator group

Description:

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Treatment:

Drug: Avastin

Drug: Luminate 1.0mg

Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT

Active Comparator group

Description:

Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Treatment:

Drug: Luminate 0.5mg

Drug: Avastin

Avastin 1.25 mg + Sham IVT

Active Comparator group

Description:

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Treatment:

Drug: Luminate 0.5mg